When you arrive in San Diego, make your way to the registration desk in the Pacific Foyer to receive your conference badge and essential materials, ensuring you're fully equipped for ACRP 2027.

If you have questions or need assistance throughout the conference, the registration desk is where you’ll find the answers you seek.

This hands-on workshop equips clinical research professionals with practical skills to use artificial intelligence (AI) effectively, responsibly, and within organizational guardrails.

Attendees will learn how to define the work product they want to improve, develop effective prompts, evaluate outputs, and apply professional judgment when using AI in clinical research settings. This workshop also addresses practical security and responsible-use considerations, including privacy, confidentiality, human oversight, and compliance requirements. Through guided practice and application activities, attendees will develop a reusable AI workflow and a set of prompts for a recurring task, leaving with a practical tool they can apply immediately in their work.

Technology Requirements: Attendees should have access to a laptop with internet access and an AI tool approved for use in their work environment, such as an enterprise-approved platform, internal AI tool, or other permitted web-based AI tool. The workshop is designed to be tool-agnostic and is not dependent on the interface or capabilities of any single model or vendor. Attendees should follow their organization's privacy, security, and AI-use policies throughout the workshop.

CEUs: 5.5 ACRP

Trainer:

• Stephen Loosli, MSc, Principal/Founder & CEO, Boeson Research, LLC

Back by popular demand, this timely topic returns with fresh, interactive workshop scenarios, updated examples, and a deeper look at what organizations are learning as the International Council for Harmonization (ICH) E6(R3) guideline for Good Clinical Practice becomes a part of day-to-day clinical trial conduct.

Designed for newcomers and returnees alike, this year’s program expands the discussion with additional focus on how emerging lessons are shaping how teams are moving beyond early E6(R3) implementation in terms of applying risk-proportionate approaches, translating Quality by Design into trial execution, defining and demonstrating oversight, strengthening data governance, evaluating protocol deviations, and making tough but defensible decisions about what matters most.

Attendees will exchange perspectives across sponsors, contract research organizations, service providers, and investigator sites, and leave with practical tools, frameworks, and concrete actions they can put to use when they return to their organizations.

CEUs: 5.5 ACRP

Trainer:

• Leslie Sam, CQIA, SSBB, President, Leslie Sam and Associates, LLC

Are you fully prepared for a U.S. Food and Drug Administration inspection? Inspections can be high-stakes events that bring stress, potential delays, and reputational risk if not managed effectively.

This comprehensive, full-day workshop is designed to help quality, regulatory, and research professionals approach inspections with confidence, clarity, and a concrete plan. Moving beyond generic advice, the session delivers a structured, actionable framework—a blueprint for achieving and sustaining inspection readiness. Attendees will learn how to build a proactive inspection strategy, master pre-inspection preparation, assemble and train an effective readiness team, reduce risk, maintain compliance, and navigate inspection day with assurance.

The workshop emphasizes practical, real-world tactics supported by examples and interactive discussions. Attendees will leave equipped with proven tools and a step-by-step approach for transforming a daunting process into a manageable, even strategic, opportunity for operational excellence.

CEUs: 5.5 ACRP

Trainers:

• Christina Brennan, MD, MBA, FACRP, Senior Vice President, Clinical Research, Northwell Health

• Annie Carter, MBA, CRA, ACRP-CP, Vice President of Research, OneOncology

This workshop provides a practical, high-impact introduction to project management within clinical research. Attendees will learn how to effectively plan, initiate, and execute clinical trials using proven project management principles tailored to real-world site, contract research organization, and sponsor environments. Key topics include study start-up and planning, stakeholder communication, timelines and milestones, risk identification and mitigation, and oversight of vendors and trial activities. Through interactive examples and applied exercises, attendees will leave with actionable tools and frameworks they can immediately use to improve efficiency, reduce delays, and support successful trial delivery.

This training can be used for maintenance of ACRP Certification with contact hours as well as for maintenance of PMP certification with Project Management Institute-approved professional development units.

CEUs: 5.5 ACRP

Trainers:

• Mitch Hilbe, CEO, DiversiTrials

• Jess Thompson, CEO, Clinical Research Pro

Join us for the First-Time Attendee Mixer and connect with fellow newcomers and experienced ACRP attendees before the conference begins. Meet new colleagues, make connections, and get a head start on your conference experience.

RSVP is required to attend—coming soon!

Kick off ACRP 2027 in style! Join us in the Expo Hall (Pacific Ballroom) for tasty bites, refreshments, lively connections (and a few surprises!) as we start charting the course together. It’s the perfect way to mix, mingle, and set the tone for an unforgettable conference.

The ACRP California Chapters will host a reception at ACRP 2026 to celebrate their members and network with local attendees. This event is invite-only. If you would like to attend, please contact chapters@acrpnet.org.

When you arrive in San Diego, make your way to the registration desk in the Pacific Foyer to receive your conference badge and essential materials, ensuring you're fully equipped for ACRP 2027.

If you have questions or need assistance throughout the conference, the registration desk is where you’ll find the answers you seek.

Start your day in the Expo Hall (Pacific Ballroom) with a delicious breakfast and engaging conversations—connect with 50+ innovative organizations driving better results in clinical research.

Session and speaker details coming this fall!

Recharge with a shot of caffeine and a splash of conversation. Drop anchor in the Grand Foyer for a 15-minute pick-me-up before heading to your next session.

Building on foundational concepts of career development and transferable skills, this session focuses on one of the most underdeveloped yet critical competencies in clinical research: effective networking. Despite working in highly collaborative, cross‑functional environments, many clinical research professionals struggle to translate everyday interactions into meaningful professional relationships that support career growth, mentorship, and access to opportunity.

This interactive session approaches networking as a core professional competency essential for success across the clinical research ecosystem.

Attendees will explore practical, inclusive networking strategies that support authentic relationship‑building, professional visibility, and long‑term career resilience. Through real‑world examples, guided reflection, and hands‑on networking exercises, attendees will gain actionable tools to strengthen their professional presence, communicate their value effectively, and build connections they can leverage immediately—during the conference and beyond.

CEU: 1.0 ACRP

Speakers:

• Tamika Harris, Clinical Operations Manager - Regulatory, Merck

• Jessica Propps, ACRP-CP, Associate Director, Clinical Operations, Merck

This session will explore the current state of clinical research workload tools available and compare several similar adaptations of the Clinical Research Workload Tool in tracking productivity at various types of research programs.

The model to be presented offers great flexibility in both oncology and non-oncology settings, as it allows for continuity of care amongst study coordinators for their study participants. These metrics can be used to justify new and existing employees for research programs running clinical trials predominately on the high end of the acuity continuum. In addition, the metrics can be used to increase funding for additional coordinator and support staffing while improving study coordinator job satisfaction and retention at sites. This allows sites to achieve their enrollment goals and promote progress in their clinical research practice. In the wake of such improvements, research programs can expect more funding opportunities and greater success.

CEU: 1.0 ACRP

Speaker:

• Suzanne Rose, MS, PhD, CCRC, FACRP, Executive Director of Research, Stamford Health

Start-up activities for clinical trials present many operational challenges for sites and sponsors/contract research organizations (CROs), especially when increasingly complex protocols and investigational products are at play. The need to thoroughly evaluate study designs, budgets, and site staff availability to ensure operational success has become a priority so that sites and sponsors/CROs are utilizing their resources appropriately. As the research industry continues to lean toward expediting timelines, a streamlined and cohesive process for start-up activities is necessary.

This session will explore the differing needs for start-up between a site and a sponsor /CRO and how robust communication and collaboration between all parties can foster a successful and efficient start-up process.

CEU: 1.0 ACRP

Speakers:

• Jennifer Davis, Project Director, Clinical Trial Management, Medpace

• Heather Campbell, Site Director, Highlands Oncology

Artificial intelligence (AI) is changing how clinical research professionals work, but it's the people in the trenches who still drive understanding, trust, and progress in the enterprise. This session provides attendees with practical tools for using AI in their daily work while strengthening the human communication skills needed to turn information into alignment and action. Simple, non-technical methods for organizing one's thinking, drafting clearer messages, preparing for meetings, and building better prompts will also be shared.

The session then moves to practical communication techniques that help professionals frame conversations, listen with context, ask difficult questions early, reduce surprises, read reactions, and confirm what people actually heard. Through realistic scenarios, attendees will gain tools they can use immediately with sponsors, contract research organizations, sites, vendors, and other stakeholders to improve clarity, trust, decision-making, and follow-through.

CEU: 1.0 ACRP

Speakers:

• Gary Fiocco, CEO, PCRS Network, LLC

• Kalli Kniss, President/COO, PCRS Network, LLC

• John Neal, Founder & Chairman of the Board, PCRS Network, LLC

Contract research organizations and sponsors collect a wealth of operational data, yet many metrics are used only for reporting rather than also for decision-making based on how they can be connected across the study lifecycle to identify trends and anticipate challenges.

This session will explore how clinical research professinals can move beyond reporting metrics and use operational data to support proactive planning, improve efficiency, and optimize study outcomes. Through interactive discussion and practical examples, attendees will examine common study start-up and monitoring metrics, including activation timelines, site performance indicators, monitoring workload, and quality measures, and leave with a practical framework for transforming operational data into actionable insights that support more effective study planning and execution.

CEU: 1.0 ACRP

Speakers:

• Elizabeth Feathers, BS, ACRP-CP, Clinical Operations Manager, NMDP

• Kassandra Nealon, BS, ACRP-CP, Clinical Operations Manager, NMDP

This session will focus on a high-impact site management model that addresses the critical industry gap whereby only 3% of physicians participate in clinical research. The presenter will demonstrate a comprehensive Sub-Investigator Training Checklist for transforming clinical practitioners into research-competent leaders who can assume authority and accountability for the ethical conduct of a study.

The core of the checklist's success lies in a "Physician-First Informed Consent" approach: by ensuring sub-investigators are expertly trained in critical trial-related procedures, they are equipped to relay protocol intricacies directly to their established patient base. This established trust ensures participants are not only enrolled but remain deeply engaged throughout the study lifecycle. The evidence-based methodology that utilized this training framework to achieve a sustained 98.9% participant retention rate will be discussed, providing attendees with a scalable blueprint for bridging the gap between clinical practice and research excellence.

CEU: 1.0 ACRP

Speaker:

• Khutaija Noor, MBBS, FCR, Clinical Research Lead, Amicis Clinical Trials

Deviations that may affect patient safety in clinical trials are classified by the U.S. Food and Drug Administration and European Medicines Agency as important deviations or serious breaches, potentially leading to inspections and public disclosure. This highlights the need for research pharmacies to maintain strong quality management systems and optimize processes so they can focus on the most critical aspects of investigational product management without being burdened by unnecessary tasks. Efficient quality processes, supported by digital approaches to investigational product management, can play an important role in strengthening patient safety.

This panel session will explore practical site-level strategies, including quality process roadmaps for research pharmacies, regulatory perspectives, real-world examples of digitalized investigational product management, and pharmacist insights on implementing improved processes in practice.

CEU: 1.0 ACRP

Speakers:

• Hubert Lesur, ACRP-CP, CCRC, Clinical QA Consultant, GCP Auditor, Founder, HL Health Support

• Christina Shin, PharmD, Research Pharmacy Manager, UCLA Health

• Mindy Suttlemyre, BS, PhT, Director of Customer Success, McCreadie Group

Today's site-based clinical research professionals face a paradox: they receive more training than ever, yet rarely get the ongoing, applied practice needed to perform with confidence. Sponsor-led site initiation visits, compliance training, and institutional orientations stack up—then stop. What follows is a workforce left to learn on the job in high-stakes environments.

This session introduces a practical framework for building continuous learning ecosystems in clinical research programs. Drawing on a real-world initiative currently in development, presenters will share how structured ongoing training—combining case studies, role play, and applied clinical, regulatory, and financial content—can close the gap between initial training and real-world readiness. Attendees will also explore how artificial intelligence-powered simulations, gamification, and just-in-time learning tools can keep teams practicing and growing between formal training events. Attendees will leave with actionable strategies they can begin implementing immediately, regardless of program size or budget.

CEU: 1.0 ACRP

Speakers:

• Katie Moore, Research Operations Manager, Northside Hospital

• Madiha Shakir, Learning Strategist and Designer, Ullu Learning Design, LLC

Artificial intelligence (AI)-assisted trial matching is entering clinical research practice through formal tools, patient searches, vendor platforms, and informal use of public AI systems. This plain-English session will help research teams understand how AI may assist trial screening while also creating privacy, documentation, and eligibility risks. Using synthetic metastatic breast cancer patient profiles derived from actively enrolling trials identified through the Aggregate Analysis of ClinicalTrials.gov (AACT) database, attendees will examine common AI trial-matching errors without using real patient data nor protected health information (PHI).

The session will address practical safeguards, including PHI-removal checks, prompt preparation, human review of AI outputs, biomarker interpretation, prior therapy sequencing, missing-data assumptions, and overlooked exclusion criteria. Attendees will leave with coordinator-facing tools for reviewing AI-generated trial matches, documenting uncertainty, escalating eligibility questions, and keeping AI-assisted screening human-supervised, compliant, and appropriately bounded.

CEU: 1.0 ACRP

Speakers:

• Joshua Cook, M.S., Data Science; M.S., Clinical Research Management; ACRP-PM, CCRC, Clinical Research Coordinator; Adjunct Instructor, Florida Cancer Specialists & Research Institute

• William "Billy" Gonzalez Barnes, A.A., NREMT-B, Student, University of West Florida

Academic medical centers (AMCs) remain essential to the clinical research enterprise, yet they are operating in a rapidly shifting environment defined by sponsor‑driven timelines, accelerating artificial intelligence (AI) adoption, and increasing operational complexity. This session will explore how AMCs can strengthen and communicate their competitive position while preserving the scientific rigor, mission‑driven culture, and patient‑centered values that set them apart. Attendees will learn about the structural and operational challenges AMCs face and how these pressures are amplified in an AI‑enabled trial ecosystem.

The session will also highlight the unique advantages academic institutions bring to industry partnerships and address practical strategies for reducing site burden, improving operational agility, and preparing academic teams for AI‑supported workflows. The session will conclude with an interactive Q&A to support real‑world application and shared problem‑solving.

CEU: 1.0 ACRP

Speaker:

• Edwina McNeill-Simaan, MSHS, EdD, CCRP, CCRC, Program Director, Vanderbilt University Medical Center

Responding to sponsor audits is one of the most stressful—and most misunderstood—tasks in clinical research. Site teams often prepare in isolation, without ever truly understanding what an auditor is looking for, how findings are interpreted, or what a response actually needs to accomplish. Meanwhile, auditors regularly receive responses that miss the point entirely.

This session flips the script. Using a dynamic role-play format, attendees experience the audit process from both sides of the process simultaneously—hearing directly from an experienced auditor while a site leader responds in real time as the principal investigator, clinical research coordinator, regulatory coordinator, and site administrator. The result is a candid, practical, and unexpectedly engaging look at what makes audit responses succeed or fail. Attendees will leave with concrete strategies to prepare their teams, craft effective responses, and approach the audit process with confidence rather than dread.

CEU: 1.0 ACRP

Speakers:

• Leslie Pimentel-Byatt, MSML, MBA, CCRC, PMP, FACRP, Director, Clinical Trials Operations, University of New Mexico Hospital

• Suheila Abdul-Karrim, CCRA, FACRP, MICR CSci, RQAP-GCP, Independent Clinical Research Consultant, Auditor & Trainer

Step into an exclusive gathering of 300 directors, managers, and executives who are shaping the future of clinical operations. Hosted in the stunning Marriott Marquis San Diego Marina on Saturday, May 1, this luncheon will be the ideal setting for strategic dialogue and networking at the highest level. Those who attend with a Full Conference, Saturday, and Weekend Registration will be able to confirm their participation this spring.

If your company would benefit from deep brand visibility and access to top-tier decision-makers in clinical research, please contact Bruce Bassin to learn how you can sponsor this high-profile event.

Break for lunch and set your direction—connect with your community, share your top takeaways with peers, and discover solutions from 50+ trailblazing organizations throughout the Expo Hall.

Clinical trial technology platforms generate millions of operational datapoints every day. Audit trails, document workflows, signature activity, task completion patterns, and user interactions are routinely captured to satisfy compliance requirements, yet most organizations use only a fraction of this information.

As clinical research increasingly focuses on predictive management and proactive oversight, operational data are emerging as powerful sources of insight into site performance, study execution, and potential risk.

This panel session will explore how organizations can move beyond compliance-focused data collection and begin using operational workflow data to identify bottlenecks, predict delays, optimize resource allocation, and improve study outcomes in support of Quality by Design, risk-based quality management, and future artificial intelligence-enabled decision making.

CEU: 1.0 ACRP

Speaker:

• Andrea Bastek, VP of Market Strategy, Florence Healthcare

Clinical research sites remain burdened by manual data re-entry across electronic source (eSource) and sponsor electronic data capture (EDC) systems, creating avoidable duplication, verification burden, and added query resolution for coordinators and research teams.

This session explores how connected eSource-to-EDC integration streamlines data flow from site-managed workflows into sponsor-selected EDC platforms while preserving each organization's preferred technology. ​Using a real-world example of data integration as a model, the session shows how connected systems move data securely in both directions. Drawing on deployments at leading institutions and sponsor-reported gains in data quality, panelists will share implementation considerations, organizational value, and lessons learned from advancing a vendor-agnostic, connected-data ecosystem.

Attendees will leave with practical criteria for evaluating eSource-to-EDC integrations within their own organizations.

CEU: 1.0 ACRP

Speakers:

• Chin Weerappuli, VP, Provider Development, IgniteData

• James Wurdeman, SVP Product Lead, Advarra

Clinical trial success depends on more than protocol execution—it requires alignment between financial strategy and operational realities. This session will explore how clinical research teams can bridge the gap between study budgets, invoicing, visit execution, and site workload management. Through real-world case studies, attendees will learn how operational inefficiencies directly impact financial sustainability, staff burnout, and trial performance. Topics include hidden operational costs, third-party vendor impacts, invoiceable activities, budget negotiation strategies, and communication workflows between finance and study teams. Attendees will leave with practical tools to improve budget forecasting, operational transparency, and cross-functional collaboration while maintaining compliance and study quality.

CEU: 1.0 ACRP

Speakers:

• Kayleen Murphy, Training and Education Lead, Innovo Research

• Brittany Regler, MHA, Senior Manager of Revenue Operations, Innovo Research

Clinical research has over-indexed on evidence of staff training and under-indexed on evidence of staff judgment. Training records, standard operating procedure acknowledgments, and completion logs are often treated as proof of readiness to engage in clinical trial activities, but completion does not guarantee applied competence. This advanced session examines how training complacency can create false confidence, weaken escalation behavior, and affect participant safety, data integrity, and trial quality. Attendees will explore how cognitive and organizational biases influence how teams interpret training, oversight, readiness, and risks to quality. Through practical scenarios, attendees will be challenged to rethink training as more than documentation and consider how workforce development can build applied judgment, constructive engagement, and active confidence when faced with ambiguous or uncomfortable situations. Attendees will leave with strategies to strengthen training programs, coaching practices, and team behaviors that support defensible quality decision-making beyond the training log.

CEU: 1.0 ACRP

Speakers:

• Mitch Hilbe, CEO, Diversitrials

• Jess Thompson, CEO, Clinical Research Pro

Today’s potential clinical trial participants are more “informed” than ever about their conditions—having Googled the diagnosis, watched TikTok segments about it, and asked artificial intelligence-driven chatbots for insights—yet more information rarely turns into action. This session focuses on the elements of Clinical Research as a Care Option, built on a foundation often treated as a one-time formality: health literacy, managed deliberately from informed consent through the end of the trial, including for those who screen-fail. When participation is framed not only as a contribution to better science but as a chance to learn more about one’s own body, sites pique interest, build trust, and empower people in ways that drive participation. Through real scenarios and interactive discussion, attendees will pinpoint where the hand-off from “informed” to “engaged” actually happens, and leave with practical ways to manage literacy across the participant journey—turning consent into comprehension, screen failures into trust-building moments, and curiosity into sustained, science-strengthening participation.

CEU: 1.0 ACRP

Speaker:

• Chinonso (Chino) Ahanonu, MS | Doctoral Candidate in Health Sciences, Director of Community Engagement, Acclinate

Effective collaboration between principal investigators (PIs) and institutional review boards (IRBs) is critical to protecting participants and ensuring efficient study conduct, yet misalignment between these groups remains a persistent challenge.

This session offers dual perspectives from an IRB reviewer and an experienced PI/IRB chair on how decisions are made, interpreted, and sometimes contested across the research lifecycle. Using real-world, case-based scenarios, attendees will be walked through high-friction moments in IRB–PI interactions, including disagreements about informed consent in complex or time-sensitive settings, protocol design concerns and risk-benefit assessments, and responses to deviations, noncompliance, and evolving safety signals.

This session will emphasize how regulations are implemented in practice, highlighting the underlying reasoning, assumptions, and common communication breakdowns in order to anticipate IRB concerns during study design and submission, improve communication, reduce iterative review cycles, and navigate disagreements constructively while maintaining participant protections.

CEU: 1.0 ACRP

Speakers:

• Muhammad Waseem, MD, MS, Research Director, Emergency Medicine, Lincoln Medical Center

• Ribu Goyal, IRB Specialist and Scientific Reviewer, Mayo Clinic

Take a breather and make meaningful connections—mingle with exhibitors and colleagues in the Expo Hall during this extended afternoon networking break.

Site training remains a persistent source of inefficiency in clinical research that is marked by redundant requirements, fragmented delivery, and heavy documentation burden.

This panel session will introduce a new approach that reframes training around demonstrated competency, role relevance, and reuse of existing knowledge. Representing sponsor, contract research organization, and two distinct site perspectives, the panelists will challenge entrenched training practices—such as repeated Good Clinical Practice and technology system training—that may exceed what is necessary to demonstrate competency and qualification under regulatory expectations.

The session will also introduce a practical framework that distinguishes study-agnostic from study-specific training. Attendees will gain actionable strategies to streamline training, accelerate study activation, and improve study execution.

CEU: 1.0 ACRP

Speaker:

• Christine Senn, PhD, FACRP, CCRC, CPI, SVP, Site-Sponsor Innovation, Advarra

Clinical research quality is traditionally managed through procedural oversight and auditing. However, the greatest threat to data integrity often resides in the "human factor"—specifically, the structural burnout produced by systemic organizational misalignment. This session will reframe workforce instability as a critical risk factor according to International Council for Harmonization (ICH) E6(R3) quality management system expectations.

Utilizing the Structural Analysis of Social Behavior diagnostic, the presenter will examine how behavioral friction in leadership and study teams creates "noise" that compromises protocol adherence and data accuracy. Attendees will learn to identify these behavioral risk indicators before they manifest as critical audit findings, thus moving beyond reactive Corrective and Preventive Action plans toward a proactive Quality by Design approach that protects the integrity of clinical data by stabilizing the human infrastructure that generates it.

CEU: 1.0 ACRP

Speaker:

• Ashley Gibson, MEd, MFA, NCC, LRC, Founder & Principal Strategist, Meaning in Practice

The U.S. Food and Drug Administration’s draft Diversity Action Plan expectations have made diverse trial enrollment a strategic priority for sponsors—yet the institutional, relational, and community-level work that makes diverse enrollment possible happens at sites, with patients, and across organizations that no single voice can fully describe. This four-person panel session brings together a director from a safety-net hospital, a cancer survivor and patient advocate, a pharmaceutical sponsor representative, and an academic clinical research site physician leader to discuss their perspectives about diverse enrollment.

The session is a structured performance where each of the three learning objectives is anchored by a panelist and other views are raised in counterpoint. Attendees will leave with insights into structural barriers, trust-building practices, and an inter-institutional referral pathway framework they can adapt to their own workplace contexts.

CEU: 1.0 ACRP

Speakers:

• Jeanette Carter, Cancer Survivor / Patient Advocate

• Colleen Dodson-Honore, Healthcare Executive Director, Genentech - A Member of the Roche Group

• Vijayakrishna Gadi, MD, PhD, Professor & Director of Medical Oncology / Deputy Director, UIC Cancer Center, University of Illinois Chicago

• Claude Hall, Jr., MA, MHA, Director, Office of Government Grants Administration / Chair, Mount Sinai Hospital IRB, Sinai Health System

Decentralized clinical trials (DCTs) offer important benefits, including improved participant access, greater convenience, expanded geographic reach, and opportunities to reduce barriers to research participation. As DCT models continue to evolve, they also introduce new stakeholders, including vendors, home health providers, remote study personnel, and digital platforms, which can create uncertainty regarding roles, responsibilities, and oversight expectations. While research activities have become increasingly distributed, accountability frameworks have not always kept pace.

This session brings together perspectives from academic and commercial institutional review boards (IRBs) and site operations to examine how decentralized trial models are implemented and managed in practice. Attendees will explore how engagement determinations, regulatory frameworks, and IRB reliance models intersect in practice and how common breakdowns in accountability lead to predictable operational consequences. Attendees will leave with practical strategies to clarify roles, improve coordination, and reduce compliance risk in decentralized and multisite research environments.

CEU: 1.0 ACRP

Speakers:

• Daniela Bashllari, MHA, Assistant Director of Regulatory Affairs, Oncology Clinical Trials Support Unit (O-CTSU), University of Michigan

• Kelly FitzGerald, PhD, CIP, Executive IRB Chair & VP of IBC Affairs, WCG

• Purna Garimella, MS, CIP, RAC, Executive Director, HRPP & IRB, Indiana University

Clinical research has a workforce problem—not a shortage of candidates, but a shortage of vision about where to look. The field needs adaptive problem-solvers, professionals with precision under pressure, and people who viscerally understand the patient experience. That talent exists in communities the industry has historically overlooked: people with disabilities and others the world reads as “all adversity, no advantage.”

This session builds an evidence-based case using the first U.S. Food and Drug Administration-approved gene therapy for an inherited retinal disease to show that designing for overlooked populations produces measurable gains in patient engagement, site satisfaction, and retention. New research extends this principle to artificial intelligence-driven patient recruitment. The proof that it works at the human level is that it is already happening inside one of clinical research’s most respected professional organizations. Attendees will leave with a framework that is philosophically compelling and operationally actionable.

CEU: 1.0 ACRP

Speakers:

• Kristin Smedley, Founder, CEO, Curing Retinal Blindness Foundation

• Michael Smedley, Audio Engineer, Walt Disney Imagineering

Delayed study recruitment is one of the most persistent and costly challenges in clinical research—yet the industry continues to apply the same flawed approaches, expecting different results.

This session challenges conventional thinking and makes the case that recruitment fails not because of tactics, but because of a fundamental misalignment between sponsors, sites, and patients. Drawing on real-world case studies, attendees will examine the structural, operational, and cultural barriers that prevent these three groups from working in true partnership.

Participants will leave with a practical framework for diagnosing misalignment in their own organizations and concrete strategies to drive meaningful change—not just marginal improvements.

CEU: 1.0 ACRP

Speaker:

• Shana Shukry, Clinical Trial Consultant/Sr. Clinical Trial Manager, Saiph Clinical Trial Consulting

What do automotive assembly lines and modern clinical trials have in common? More than many people realize. As the clinical research enterprise implements the International Council for Harmonization (ICH) E6(R3) guideline for Good Clinical Practice, clinical research teams are increasingly expected to apply concepts such as Quality by Design, Risk-Based Quality Management, Root Cause Analysis, and proactive risk mitigation, many of which originated from manufacturing quality systems.

This session will translate these concepts into practical applications for clinical research professionals by exploring how “factory tools” like the 5 Whys and Fishbone (Ishikawa) diagrams can strengthen Corrective and Preventive Action plan development, improve operational workflows, and support inspection readiness. Through real-world examples, attendees will learn how to move beyond superficial findings such as “human error” to identify true systemic contributors to noncompliance and quality issues while preserving the human-centered nature of clinical trials and participant safety oversight.

CEU: 1.0 ACRP

Speaker:

• Asma Khan, MS, MBBS, CCRC, CCRP, Associate Director, PRMS & Quality, Stanford Cancer Institute

While competency-based frameworks for clinical research coordinator (CRC) development are widely discussed, many organizations struggle to operationalize them in a way that is both scalable and adaptable to their unique workflows.

This session focuses on translating such frameworks into practice through a structured, “plug-and-play” approach. Attendees will be guided through a step-by-step method for implementation within their own organizations, regardless of size or structure, with attention paid to defining role-specific expectations, mapping CRC competencies to daily responsibilities, and establishing clear, measurable demonstration criteria. The session will also present adaptable templates, real-world examples, and lessons learned from implementation across varying levels of coordinator experience.

Attendees will leave with practical tools and a customizable model that can be immediately applied to improve onboarding, standardize competency evaluation, and support long-term workforce development.

CEU: 1.0 ACRP

Speakers:

• Jesse Fuhriman, Certified Clinical Research Coordinator, Rocky Mountain Clinical Research

• Kelsie Wetzel, Supervising Senior Certified Clinical Research Coordinator, Rocky Mountain Clinical Research

Independent research sites are navigating an increasingly complex environment shaped by consolidation, workforce challenges, evolving sponsor expectations, emerging technologies, and growing operational demands. While these changes create uncertainty, they also present opportunities for organizations whose staff and leaders are willing to adapt and evolve.

This session explores practical strategies research site professionals can use to strengthen resilience, improve operational performance, and position themselves for long-term success. Attendees will examine industry trends, assess organizational risks and opportunities, and evaluate approaches for workforce development, patient engagement, operational efficiency, strategic partnerships, and sustainable growth.

Using real-world examples and interactive discussion, attendees will leave with practical tools to assess organizational readiness and develop actionable plans to remain competitive, adaptable, and patient-focused in an evolving clinical research landscape.

CEU: 1.0 ACRP

Speakers:

• Gary Fiocco, CEO, PCRS Network, LLC

• Kalli Kniss, President/COO, PCRS Network, LLC

• John Neal, Founder & Chairman of the Board, PCRS Network, LLC

Strategic use of a clinical trial management system (CTMS) and integrated reporting tools is essential to operating high-performing clinical research sites. In this session, leaders from a national site network and a large academic medical center will share how robust reporting strategies and data governance standards drive operational efficiency, strengthen compliance oversight, and enhance financial transparency. The discussion will highlight how advanced analytics, forecasting capabilities, milestone tracking, and revenue dashboards support proactive risk management and improve sponsor performance. Attendees will gain a practical framework for transforming site-level data into enterprise-wide insights that enable financially sustainable growth.

CEU: 1.0 ACRP

Speakers:

• Angela Campbell, Senior Director, Clinical Trials Office, OSU Comprehensive Cancer Center

• Ginger Switzer, SVP Clinical Operations, Alliance for Multi-Specialty Research, LLC

Repeat audit and inspection findings often persist because Corrective and Preventive Action (CAPA) plans are written to close findings and not to solve the underlying process failures. This session will provide a practical framework for strengthening CAPA in clinical research using real-world case studies, root cause analysis methods, and effectiveness check strategies aligned to current regulatory expectations.

Attendees will examine common CAPA breakdowns, distinguish corrective from preventive actions, and learn how to build action plans that are specific, measurable, sustainable, and more likely to prevent recurrence. Through interactive discussion and applied examples, attendees will leave with practical approaches they can use to improve inspection readiness, strengthen quality systems, and reduce repeat findings across site and study operations.

CEU: 1.0 ACRP

Speaker:

• Pamela Gonzalez, Education & Research Director, Huron

Despite a growing emphasis on participant-centered clinical research, many informed consent forms, recruitment materials, and participant communications remain difficult for patients and caregivers to understand. Poor health literacy can negatively affect informed decision-making, recruitment, retention, and participant engagement. This interactive session will provide attendees with a practical framework for developing, evaluating, and maintaining health-literate research materials by incorporating plain language, stakeholder engagement, and user-centered design throughout the process. The session will cover focus groups, usability testing, iterative review cycles, and approaches for assessing both technical accuracy and participant understanding. Attendees will also explore best practices for culturally and linguistically appropriate translations and engage in hands-on activities to evaluate and redesign research materials using health literacy principles and accessibility tools. They will leave with practical templates, checklists, and usability testing resources that can be immediately applied within their research programs.

CEU: 1.0 ACRP

Speaker:

• Aimee Pehrson, PhD, MHA, MPH, Health Research/Evaluation Consultant, Verum Health Sciences, LLC

Connect with colleagues, meet new faces, and mingle with 50+ leading-edge organizations and suppliers helping move clinical research forward.

Enjoy a beverage, light hors d’oeuvres, and the energy of the Expo Hall as you connect with peers and discover what’s happening across the industry.

Connect with the ACRP and Academy Boards of Trustees, Committees and Council members, Fellows, Certification Milestone Recipients, and other key supporters at this reception to thank you for your contributions to the organization.

This event is sponsored by

The registration desk is your go-to resource for questions, assistance, or anything you need throughout ACRP 2027.

Stop by the Pacific Foyer for help with your conference badge, materials, or navigating your conference experience in San Diego.

Start your day in the Expo Hall with a delicious breakfast and engaging conversations—connect with 50+ innovative organizations driving better results in clinical research.

Session and speaker details coming this fall!

Take a breather and make meaningful connections—mingle with exhibitors and colleagues in the Expo Hall during this extended networking break.

Human gene therapy trials may require clinical research teams to coordinate two distinct but connected oversight processes: institutional review board (IRB) review and institutional biosafety committee (IBC) review. When teams are unclear on how these reviews differ, where they intersect, or when coordination should occur, study start-up can stall.

This session will clarify the IBC’s role in assessing biosafety risks, containment considerations, and institutional responsibilities while showing how coordinated IBC–IRB review can support participant safety, ethical oversight, and efficient study start-up.

Attendees will examine practical collaboration points across submission planning, review sequencing, communication, amendments, and ongoing safety oversight. Using real-world operational scenarios, the session will help site, regulatory, and study management professionals recognize avoidable delays, close oversight gaps, and build more connected review workflows for human gene therapy and engineered genetic material research.

CEU: 1.0 ACRP

Speaker:

James Riddle, MCSE, CIP, CPIA, CRQM, SVP Global Review Operations, Advarra

Efforts to improve enrollment and representation in clinical trials must go beyond recruitment tactics to address systemic barriers, mistrust, and lack of awareness.

This session presents real-world case studies from community engagement efforts undertaken from 2023 to 2026 in dozens of cities across the U.S., showcasing how community-centered partnerships can drive meaningful and lasting engagement and measurable impact.

The session draws on mobile exhibits and community event engagements held, for example, at farmers and food markets, historically black colleges and universities, cultural festivals, and health fairs. These initiatives fostered dialogue and sustained interest, with impact metrics revealing significant increases in understanding of and willingness to participate in clinical research.

One speaker from a nonprofit organization and two research sponsor representatives will share testimonials from stakeholders and insights on designing and executing inclusive engagement strategies, co-developing culturally responsive materials, and collecting operational key performance indicators to inform future engagement.

CEU: 1.0 ACRP

Speaker:

• Behtash Bahador, Senior Director, Community Engagement & Partnerships, Center for Information and Study on Clinical Research Participation, Inc. CISCRP

Clinical research coordinators face data-entry challenges that go far beyond "copy and paste." A single lab value from one report often needs to be entered into three or more separate electronic case report forms. A source document reports an exact number, but the form asks for a range. Units in the electronic health record (EHR) don’t match what the electronic data capture (EDC) system expects. And buried in pages of physician notes is the one clinical detail needed for a single field. These tedious and error-prone tasks consume hours that could be spent with patients. Artificial intelligence (AI) is built for exactly these problems. This session breaks down the specific pain points of EHR-to-EDC data transfer and shows how AI handles each one: mapping one value to multiple forms, converting units, translating values to ranges, and parsing unstructured clinical notes.

CEU: 1.0 ACRP

Speaker:

• Tejasva Jaitly, Founding Engineer, Truco

Clinical trials are often described as complex, but complexity alone does not explain why some studies struggle more than others. Some trials are operationally fragile: small disruptions in staffing, scheduling, participant availability, caregiver involvement, vendor performance, budget assumptions, endpoint execution, or communication pathways can quickly lead to enrollment delays, protocol deviations, site fatigue, participant dropout, budget disputes, and data quality concerns.

This session will introduce an Operational Fragility Framework for identifying clinical trial risk before enrollment begins.

Attendees will learn how to apply the framework for recognizing when trial fragility emerges during feasibility, site selection, budget review, study start-up, and operational planning and then, using real-world clinical operations examples, how to distinguish between trials that are merely complex and trials that require enhanced operational mitigation.

CEU: 1.0 ACRP

Speaker:

• Tia Warrick, Chief Executive Officer, Lesous Consulting LLC

This session explores how professional credentials are perceived and valued within the clinical research workforce, drawing directly from a mixed-methods research study examining both employer and clinical research professional perspectives. Attendees will review how micro-credentials, professional certifications, academic degrees, and combinations of credentials influence hiring decisions, career advancement, and professional development. The session will highlight areas of alignment and disconnect between employer expectations and employee experiences. Attendees will gain insight into how credentialing decisions shape workforce development, equity, and career mobility in clinical research, as well as how data from surveys and focus groups can inform institutional and individual credentialing strategies. The session is designed for research staff, hiring managers, educators, and workforce development leaders seeking evidence-informed approaches to credentialing decisions.'

CEU: 1.0 ACRP

Speaker:

• Jessica Fritter, DHSc, MACPR, ACRP-CP, FACRP, Associate Clinical Professor & Director, Master of Clinical Research and Certificate Programs, The Ohio State University

Emerging biotechnology companies are increasingly required to launch complex clinical trials under aggressive timelines, constrained budgets, and lean internal infrastructures. Traditional operational models and rigid outsourcing structures can create inefficiencies that delay study start-up, slow decision-making, and hinder execution.

This session will explore how agile clinical operations strategies, fit-for-purpose resourcing models, and collaborative sponsor/contract research organization (CRO) partnerships can accelerate study start-up while maintaining quality and oversight. Drawing from real-world experiences across Phase I-III global clinical programs, attendees will gain practical and proactive approaches for improving cross-functional alignment, streamlining communication and governance, managing start-up risks, and implementing scalable operational models that support efficient trial execution in today’s evolving clinical development environment.

CEU: 1.0 ACRP

Speaker:

• Shaily Garg, CEO, Exact Clinical Research

Clinical research sponsors face increasing pressure to design studies that balance therapeutic innovation, commercial expectations, and regulatory requirements. Misalignment among these drivers can result in operational inefficiencies, poor evidence generation, delayed decision-making, and risk of program failure.

This session explores practical approaches to strengthening governance and oversight frameworks that enhance the quality and predictability of study execution.

Attendees will gain insights on implementing early cross-functional governance strategies, designing quality-focused oversight frameworks, and fostering transparency and communication across sponsor stakeholders.

CEU: 1.0 ACRP

Speakers:

• Sara Garbin, Clinical Development Manager, Philips

• Sara Trbojevic, PhD, Clinical Development Scientist, Philips

Future-proofing the clinical research enterprise begins with the professionals who power it, although they have long struggled with overlooked professional identities and contributions, inconsistent job classifications, and persistent turnover. Despite a widely accepted competency framework and innovative approaches to training, hiring, onboarding, and retention being available, clear pathways into roles across diverse site, sponsor, and  contract research organization settings remain elusive. Apprenticeships offer a proven, competency-based answer: industries across the economy use them to develop high-quality early talent and build durable pipelines. This session describes how a taskforce network enabled two academic medical centers to co-create two distinct but aligned employer-based apprenticeship models, leveraging the complementary strengths of each. Now in years two and three, both models point toward a more resilient future for early-talent development.

Speakers:

• Michelle Jenkerson, RN, BS, CCRC, RRT, CPFT, Associate Director, Center for Clinical Studies, Workforce Development, Institute for Clinical and Translational Sciences, Washington University Medicine

• Denise Snyder, MS, RD, FACRP, Associate Dean for Clinical Research, Duke University School of Medicine

• Sharleen Traynor, PhD, MPH, ACRP-CP, Program Director, Clinical Trials Research Associate Program, Durham Technical Community College

Clinical research professionals are increasingly exploring consulting careers and flexible professional pathways. However, transitioning from traditional employment into consulting can be challenging, with limited practical guidance on evaluating readiness, positioning expertise, generating opportunities, and navigating the realities of independent work.

This interactive panel session brings together experienced consultants from clinical operations, site operations, and quality oversight to provide candid, experience-based perspectives on consulting in clinical research.

Through facilitated discussion, audience polling, and a practical Consulting Readiness Assessment Tool, attendees will explore consulting realities, risks, and readiness considerations, including expertise alignment, independent thinking, adaptability, business development approaches, and delivery expectations.

CEU: 1.0 ACRP

Speakers:

• Suheila Abdul-Karrim, CCRA, FACRP, MICR CSci, RQAP-GCP, Independent Clinical Research Consultant, Auditor & Trainer

• Leslie Sam, CQIA, CSSBB, President, Leslie Sam and Associates, LLC

• Yamile Sanchez, MBA, ACRP-PM, CCRP, Clinical Research Consultant, iNet Advisory Group

Clinical research sites routinely lose revenue they rightfully earned—not from poor science, but from a fragmented flow of funds. Budgets, contracts, protocols, and financial activity are siloed, rarely reconciled, and nearly impossible to monitor in real time. This session introduces a practical end-to-end cost recovery framework that treats artificial intelligence (AI) as a budget reconciliation engine: systematically comparing what the institution agreed to do, what the sponsor agreed to pay, what the site expected to spend, and what actually occurred.

Attendees will map the most common failure points in the revenue lifecycle, examine where reconciliation typically breaks down, and leave with actionable strategies they can implement immediately. Particular attention will be given to scalable and equitable approaches that serve institutions of all sizes, ensuring that stronger financial infrastructure translates directly into reinvestment in the research mission.

CEU: 1.0 ACRP

Speaker:

• Shreya Singh, Senior Associate, Huron Consulting Group

• Eric Tomasini, Managing Director, Clinical Research Solution Leader, Huron Consulting Group

What happens after a U.S. Food and Drug Administration (FDA) inspection can affect regulatory risk, business continuity, and compliance in clinical trial settings. This session will explain the FDA’s post-inspection process and outcomes, including FDA Form 483 (Inspectional Observations), Establishment Inspection Reports, Untitled Letters, Notice of Initiation of Disqualification Proceedings and Opportunity to Explain letters, and determinations of No Action Indicated, Voluntary Action Indicated, and Official Action Indicated.

Attendees will learn how the Agency evaluates findings, reviews responses, and decides next steps, and will gain a practical understanding of the key documents issued at the end of an inspection and FDA decisions that can lead to Warning Letters or enforcement. With a focus on root cause analysis and Corrective and Preventive Action Plans, this session will explain what each outcome means from regulatory and operational perspectives, helping attendees anticipate risk, prioritize responses, and communicate effectively across teams. Attendees will leave with practical strategies and greater confidence in managing observations, reducing escalation risk, and improving inspection readiness.

CEU: 1.0 ACRP

Speaker:

• Janet Holwell, CCRC, CCRA, TIACR, FACRP, Clinical Research Consultant/Trainer, Holwell Clinical Research Consulting

Artificial intelligence (AI) tools are increasingly being used across clinical trial workflows for note drafting, protocol summarization, communication support, document review, and operational assistance. However, many clinical research professionals remain uncertain about how HIPAA, confidentiality obligations, sponsor agreements, and privacy expectations apply when using these technologies in daily research activities.

This session provides a practical discussion of common AI-use scenarios encountered across sites, contract research organizations, sponsors, and institutional review boards. Through real-world examples and interactive audience discussion, attendees will explore where privacy and confidentiality risks may emerge and how to recognize operational red flags before inappropriate disclosure occurs, helping them build safer habits for AI use within clinical research environments.

CEU: 1.0 ACRP

Speaker:

• Sahar Zahid, MD, Graduate Student, Arizona State University

An exclusive, invitation-only event honoring the 2027 Class of Fellows and offering a special opportunity to connect with peers.

Break for lunch and keep moving in the right direction—connect with your community, reflect on your top takeaways, and discover solutions from 50+ trailblazing organizations throughout the Expo Hall.

Clinical research coordinators are facing unprecedented burnout, largely driven by the tedious, manual data transcription between electronic health record (EHR) and electronic data capture (EDC) systems. To address this operational crisis, a recent study directly quantified the impact of EHR-to-EDC automation on site staff’s mental workload. This session will reveal real-world data demonstrating how seamless integration slashes cognitive load, reduces task-related frustration, and reclaims critical hours per patient visit. Attendees will discover how alleviating this administrative fatigue directly empowers coordinators to reallocate their energy toward patient care and protocol compliance. Finally, actionable strategies will be outlined for sites and sponsors to leverage interoperability tools as a strategic weapon against coordinator turnover.

CEU: 1.0 ACRP

Speaker:

• Samir Jain, Head of EHR and Interoperability Solutions, Medidata, a Dassault Systèmes company

Back for its third year, the ACRP Game Show brings clinical research knowledge to life through fast-paced competition, audience participation, and a healthy dose of fun. Teams of clinical research professionals will go head-to-head in a lively trivia showdown covering topics such as ICH-GCP principles, eClinical technology, informed consent, regulatory requirements, and other key areas of the profession.

But the action is not limited to the stage. Audience members are encouraged to play along, test their own knowledge, cheer on their colleagues, and see how they stack up against fellow attendees as the competition unfolds. With unexpected twists, friendly rivalry, and opportunities to learn along the way, every round keeps participants engaged.

Whether you are a seasoned professional or new to clinical research, come ready to challenge yourself, join the conversation, and enjoy an interactive session that combines learning, teamwork, and plenty of fun.

CEU: 1.0 ACRP

Speaker:

Elisa Cascade, MBA, FACRP, Chief Growth Officer, TrialScreen

Clinical research does not end when a protocol is executed, data are cleaned, or a study report is complete. This session introduces medical communications as a practical, cross-functional bridge between clinical operations, evidence generation, technology platforms, and the patients and professionals the research is meant to serve. Using real-world, noncommercial examples, attendees will examine how study teams can plan for evidence translation earlier in the research lifecycle, connect trial execution decisions to downstream communication needs, and use integrated tools and workflows to improve clarity, consistency, and reach.

Panelists for this session will emphasize how attendees can partner with colleagues from other realms of stakeholders in the research to craft effective communications without compromising scientific rigor, compliance, or operational quality. Attendees will leave with a replicable framework for turning well-run research into credible, accessible, and actionable evidence.

CEU: 1.0 ACRP

Speakers:

• Maureen Jahraus, BS, MBA, Global Head, Medical Communications, Resmed

• Fatima Sert, PhD, Director Clinical Research, Americas, Resmed

The International Council for Harmonization (ICH) E6(R3) guideline for Good Clinical Practie fundamentally reframes the role of principal nvestigators (PIs) in clinical trial oversight—moving beyond task delegation to genuine, demonstrable accountability. Yet across sites and institutions, the most common response to E6(R3) has been procedural: updating the Delegation of Authority log and moving on.

This session challenges that approach. Drawing on real-world monitoring and audit scenarios across Phases I–IV, this advanced session examines what genuine PI oversight looks like in practice—and where the gaps between regulatory intent and site-level execution create the most significant compliance risk.

Topics include the distinction between task delegation and oversight delegation, PI accountability for data integrity and safety reporting, and how sites can build infrastructure that makes PI oversight visible, documentable, and sustainable under E6(R3) scrutiny. Attendees will leave with a framework for translating E6(R3)'s strengthened investigator requirements into operational site standards.

CEU: 1.0 ACRP

Speaker:

• Andrea Arruda, Principal Consultant & Founder, pharmaDev Consulting

Mentoring in clinical research is often misunderstood as a formal, structured program featuring matched pairs, monthly meetings, and a checklist of milestones. But the most transformative mentoring relationships rarely look like that. They happen across unexpected boundaries: a leader who sees potential before the mentee does, a difficult boss who inadvertently teaches everything about integrity, a trusted advisor from outside the field who asks the questions no one inside it will.

This session challenges clinical research professionals to expand their definition of mentoring—as both recipients and providers of guidance. Drawing on real-world examples across career stages and settings, attendees will explore what makes mentoring relationships effective, how to intentionally cultivate them, and how to become the kind of mentor the next generation of clinical research professionals actually needs. Attendees will leave with practical tools to identify, build, and sustain mentoring relationships that advance both individuals and the field at large.

CEU: 1.0 ACRP

Speaker:

• Leslie Pimentel-Byatt, MSML, MBA, CCRC, PMP, FACRP, Director, Clinical Trials Operations, University of New Mexico Hospital

Take a breather and make meaningful connections—mingle with exhibitors and colleagues in the Expo Hall during this extended afternoon networking break.

Launching a medical device clinical trial for a U.S.-based sponsor in a different global region requires more than regulatory approval and site selection. It requires practical coordination across sponsor teams, local site leadership, investigators, monitors, vendors, and study operations teams. Through a case study approach, panelists for this session will examine the start-up of a multisite medical device study in Saudi Arabia, from feasibility and site qualification through site initiation, activation, screening, and early enrollment. Panelists will discuss what worked, what required adaptation, and what clinical operations teams should consider when executing studies across geographies, cultures, time zones, and healthcare systems. Attendees will leave with practical lessons on site readiness, communication cadence, role clarity, patient recruitment, issue escalation, and sponsor-site collaboration in global medical device trials.

CEU: 1.0 ACRP

Speakers:

• Muath AlGhamdi, Clinical Research Specialist, Trial Forward

• Ryan McFadden, Lead Clinical Research Associate, Dexcom Inc.

• Kunal Sampat, Founder & CEO, Trial Forward

The International Council for Harmonization (ICH) E6(R3) guideline for Good Clinical Practice is reshaping expectations for site readiness, documentation, and access to trial records. This session will prepare clinical research professionals to distinguish between routine interim monitoring visits, audits, and inspections, and to understand what their respective expectations mean in practice. Attendees will review what remains foundational, including timely institutional review board reporting, documentation readiness, and investigator site file maintenance, while examining areas of increased emphasis such as electronic system validation, audit trails, direct access to source documents and site facilities, and inspection-ready processes.

The session will also address practical considerations for pre-study visits, site initiation visits, and interim monitoring visits, including what site teams and partners should confirm before monitoring, audit, or inspection activity occurs. Attendees will leave with a clearer framework for preparing sites, identifying readiness gaps, and supporting compliant, well-documented clinical trial conduct.

CEU: 1.0 ACRP

Speaker:

• Lella Baker, Sr. Consultant, GxP Services

Strong leadership principles are easy to endorse but far more difficult to apply when stakes are high, timelines are compressed, and decisions carry real consequences. In clinical research, leaders are routinely called upon to navigate protocol deviations, audit findings, cross-functional conflict, and team burnout—often with incomplete information and competing priorities.

Building on the foundational “Four Cs” of leadership—Character, Competence, Caring, and Communication—this session moves beyond theory to explore how these principles show up in real-world, high-pressure situations. Through case-based scenarios, the presenters will examine how effective leaders balance integrity with urgency, empathy with accountability, and clarity with complexity. Attendees will engage in guided decision-making exercises, explore common leadership missteps, and apply practical frameworks to respond to challenging situations with greater confidence and consistency.

Attendees will leave with actionable strategies to strengthen decision-making, foster trust, and lead effectively through the complexity and ambiguity inherent in clinical research environments.

CEU: 1.0 ACRP

Speakers:

• Christina Brennan, MD, MBA, FACRP, Senior Vice President, Clinical Research, Northwell Health

• Elisa Cascade, MBA, FACRP, Chief Growth Officer, TrialScreen

• Christine Senn, PhD, FACRP, CCRC, CPI, SVP, Site-Sponsor Innovation, Advarra

Patient recruitment remains one of clinical research's most persistent bottlenecks: most trials miss enrollment timelines and many sites struggle to identify eligible participants within their own records and communities. Artificial intelligence (AI) is rapidly changing how recruitment is approached, from automated eligibility matching and natural language processing of clinical records to AI-assisted prescreening and outreach. This session offers a practical, vendor-neutral look at where AI can meaningfully support site recruitment and where human judgment remains essential. Attendees will examine the major categories of tools entering the field, learn a framework for evaluating their accuracy, fit, and limitations, and explore the safeguards that responsible adoption demands in terms of informed consent, data privacy, institutional review board oversight, and algorithmic biases. Through real-world scenarios and open discussion, participants will leave with concrete questions to ask and first steps to take when considering AI for their own recruitment efforts.

CEU: 1.0 ACRP

Speaker:

• Rishabh Goel, CEO, Bond Health, Inc.

Clinical trial teams continue to struggle with fragmented processes across sites, sponsors, and contract research organizations. Documents, milestones, and study data often reside in disconnected systems, creating duplication, delays, compliance risks, and increased administrative burden.

This session will explore how organizations could build artificial intelligence (AI)-connected clinical ecosystems through the integration of site and sponsor technologies, including electronic investigator site files, electronic trial master files, and clinical trial management systems. Using real-world implementation examples and lessons learned, attendees will examine practical integration models, governance considerations, and change management strategies that improve collaboration, streamline document exchange, enhance inspection readiness, and reduce operational inefficiencies.

Attendees will leave with actionable approaches to evaluate integration opportunities within their own organizations and strengthen sponsor-site partnerships throughout the study lifecycle.

CEU: 1.0 ACRP

Speaker:

• Guillaume Gerard, Chief Operating Officer, Agatha Inc

The International Council for Harmonization (ICH)  E6(R3) guideline for Good Clinical Practice pushes trial teams to collect less, but more important, data while maintaining a focus on critical-to-quality factors, avoiding unnecessary data fields, and designing collection around the protocol’s real risks and objectives. It also shifts strategy toward risk-based quality management, stronger data governance, and fit-for-purpose digital systems with traceable audit trails. This session will examine how, in practical terms, E6(R3) means data collection planning must start during protocol design, with a clear map of which data are critical and why. For trial teams, earlier input by data management and informatics experts results in quality-driven collection, rather than volume-driven collection, with a clear path to operational success.

CEU: 1.0 ACRP

Speaker:

• Jaime Baldner, Research Informatics Director, University of Arkansas for Medical Sciences

The implementation of artificial intelligence (AI) in the clinical research space has happened at such a rapid pace that many are left asking a fundamental question: How do we know if this thing is working the way we intended? When pressed, AI vendors rarely provide error rate data or any delineation between the root causes of failure. That absence of accountability is precisely where quality professionals need to step in. AI might be new, but basic research principles still apply.

Geared toward research site staff who are implementing generative AI for source records and sponsor staff using AI to support database and protocol development, this presentation borrows directly from medical device quality methodology to build internal AI quality assurance programs. Most current quality standards were not written with AI in mind; thus, quality assurance of AI systems does not require a novel approach, it requires research.

CEU: 1.0 ACRP

Speaker:

• Michele LaBadie, ACRP - CP, MDP, PM, Clinical Trial Manager, Shoulder Innovations

Organizations involved in the conduct of clinical research lose experienced professionals at rates that compromise trial quality, inflate costs, and slow start-up. Yet most workforce interventions arrive too late, after the damage is done. This session challenges a foundational assumption: that talent management is a human resources function. It is not. It is a clinical operations function, and the decisions made before a hire, during onboarding, and in the first 90 days of performance management determine whether a team delivers or deteriorates.

Drawing on real-world case studies from contract research organization and sponsor environments, this session presents a practical, two-question performance framework that replaces analysis paralysis with actionable leadership decisions. Attendees will leave with concrete tools to reduce attrition, improve team stability, and connect staffing decisions directly to operational outcomes, including budget adherence, enrollment timelines, and scope control.

CEU: 1.0 ACRP

Speaker:

• Rend Williams, Founder and President, Foresight Business Consulting

Ready to take the next step in your clinical research career? Join this expert panel of ACRP Certified professionals—leaders who’ve served on the Academy Board, committees, as item writers, and more—to gain insider knowledge on achieving your certification.

They’ll share their personal journeys and practical strategies for success, from navigating the application process to preparing for the exam. Discover what to expect during eligibility review, explore testing options, and learn proven study tips that can help you earn the most reputable credentials in the clinical research industry. ACRP Certification goes beyond the letters—learn how it can be a catalyst for impact, opportunity, and career growth.

Please note that this session will not cover exam content. If you have questions regarding your individual certification journey, please talk to the staff at the ACRP booth in the Expo Hall.

This session does not provide ACRP Contact Hours.

Speaker:

• Jen Milam, CAE, ICE-CCP, Certification Manager, ACRP

This session will provide a high-level overview of the emerging regulatory environment governing clinical research. There are many trends to keep track of as actions by the current administration in the White House affect available funding, workforce readiness, and research priorities in governmental, academic, industry, and private practice settings. Further, recent and forthcoming updates to various U.S. Food and Drug Administration guidances, International Council for Harmonization guidelines, and more targeting ethical, safety, and efficacy concerns in the design and conduct of drug and device clinical trials will make this a valuable session for stakeholders across the entire clinical research enterprise.

CEU: 1.0 ACRP

Speaker:

• David Vulcano, CEO, ACRP

Clinical research depends on well-informed, trusting communities, yet barriers such as limited awareness, health literacy gaps, historical mistrust, and cultural disconnects prevent meaningful engagement. Given their unique position, community health workers (CHWs) have the potential to increase awareness and comprehension of clinical research in communities that have historically faced challenges in accessing research opportunities.

This session will share lessons learned from initiatives that equip CHWs with the knowledge, tools, and resources to facilitate discussions about clinical research as the presenters explore practical strategies that foster trust in research through CHW engagement.

Attendees will gain actionable insights for partnering with trusted community voices, improving research communication efforts, and building sustained community relationships that support long-term trust, informed decision-making, and representative research participation.

CEU: 1.0 ACRP

Speakers:

• Rebecca Hayes, MD, MEHP, Director of Research, Chief Medical Officer of Carolina Medical Home Network Medicare Shared Savings Program Accountable Care Organization, North Carolina Community Health Center Association

• Korrey Monroe, MPH, Research Program Manager, North Carolina Community Health Center Association

• Perla Nunes, BS, Community Outreach and Bilingual Clinical Research Dedicated, Engaged & Impactful Thought Leader, Perla Nunes Consulting

Connect with colleagues, meet new faces, and mingle with 50+ leading-edge organizations and suppliers helping move clinical research forward.

Enjoy a beverage, light hors d’oeuvres, and the energy of the Expo Hall as you connect with peers and discover what’s happening across the industry.

The registration desk is your go-to resource for questions, assistance, or anything you need throughout ACRP 2027.

Stop by the Grand Foyer for help with your conference badge, materials, or navigating your conference experience in San Diego.

Start your day in the Expo Hall with a delicious breakfast and engaging conversations—connect with 50+ innovative organizations driving better results in clinical research.

Session and speaker details coming this fall!

Recharge with a shot of caffeine and a splash of conversation. Drop anchor in the Grand Foyer for a 15-minute pick-me-up before heading to your next session.

Effective onboarding is critical to building a competent and compliant clinical research workforce—yet many programs struggle to balance standardization with real-world readiness. The Onboarding Blueprint presents a comprehensive, scalable approach that integrates live instructor-led training, clinical research preceptorship, and real-world case studies to enhance learning and application.

This session will walk attendees through a practical framework for designing and implementing a blended onboarding model that aligns with Good Clinical Practice standards, institutional policies, and evolving operational demands. The presenters will highlight common onboarding gaps, demonstrate strategies to reinforce critical thinking and protocol adherence, and share lessons learned from scaling onboarding programs across high-volume organizations.

CEU: 1.0 ACRP

Speakers:

• Mary Petrany, Education and Policy Specialist, City of Hope

• Jennifer Tugwell, Sr. Manager Clinical Research Education, Training & Policy, City of Hope

The International Council for Harmonization (ICH) E6(R3) guideline for Good Clinical Practice didn't just update language from version R2, it fundamentally shifted what regulators expect as evidence of quality oversight. Yet most midsized sponsors and contract research organizations (CROs) are still operating on R2 assumptions: reactive monitoring, fragmented trial master file oversight, and Corrective and Preventive Action plan systems that document problems without preventing them.

This session delivers an honest diagnosis of the most common R3 compliance gaps in lean organizations, a practical framework for closing them before the next inspection, and a scalable quality oversight model that doesn't require an enterprise quality assurance team to sustain.

CEU: 1.0 ACRP

Speaker:

• Wijdan Suliman, MD, Founder & CEO, HolistiNova Research

The challenge we all face in clinical research is how we balance home life and work life. This session, led by experienced clinical research associates (CRAs) in the medical device industry, will explore practical tools and strategies for achieving work/life integration and a healthy balance. From managing traveling, achieving critical trial deadlines, managing a high site load, resolving queries, writing monitoring visit reports, navigating challenging site discussions, and working in a high-pressure environment, this question becomes critical: Where do we draw the line for work?

Speakers will share real-world experiences as well as tips on self-reflection, prioritization, boundary-setting, and difficult conversations. In hopes of igniting a mindset change, this session will also touch on the positive impact remote monitoring and risk-based monitoring strategies have had on improving workloads, deliverables, and work/life balance for CRAs.

CEU: 1.0 ACRP

Speakers:

• Jodie Addington, RN, BA, CCRA, Senior Specialist, Clinical Research Monitoring, Edwards Lifesciences

• Kelly Chan-Ojowu, BS, CCRA, Manager, Clinical Research Monitoring, Edwards Lifesciences

• Misty Daniel, BA, CCRC, CCRA, Senior Specialist, Clinical Research Monitoring, Edwards Lifesciences

Artificial intelligence (AI), digital health platforms, wearable technologies, remote monitoring systems, and decentralized clinical trials are transforming the clinical research landscape; however, rapid technological advancement, participant recruitment, retention, engagement, and adherence remain persistent challenges.

This session explores how behavioral science can bridge the gap between technological innovation and successful clinical trial execution. Attendees will examine the factors that influence the adoption and effectiveness of emerging research technologies, and real-world case examples of practical strategies for improving participant engagement, supporting organizational change management, and implementing participant-centered innovation. The session provides actionable frameworks that clinical research professionals can immediately apply to strengthen technology adoption, improve participant experiences, and support successful study outcomes.

CEU: 1.0 ACRP

Speaker:

• Jon Moore, Owner/Founder, Researcher, Student, Moore Innovations South Georgia, LLC

This session explores the transformative role of real-world data (RWD) in modernizing and optimizing clinical trial design. Using a case-study based approach, attendees will learn how RWD can be applied to three high-impact areas. The first is modeling inclusion/exclusion criteria and patient attrition to simulate how changes in criteria impact the addressable patient pool and primary endpoints. The second is control arm validation and benchmarking to ensure comparator arms reflect relevant standard of care and that the trial is appropriately powered to show a statistically significant benefit. The third is evidence-based accrual metrics to facilitate site selection and build more accurate, reliable enrollment projections. Attendees will gain essential tools to transition from traditional protocol design to efficient, data-informed methodologies that ultimately accelerate study start-up, minimize protocol amendments, and significantly enhance trial accrual.

CEU: 1.0 ACRP

Speakers:

• Chelsea Osterman, MD, Executive Medical Director, Tempus AI

• Emilie Scherrer, Sr Director & Head of Outcomes Research, Tempus AI

Coverage analysis is often seen as just a billing compliance task, but it plays a much bigger role in the success of clinical research operations. This panel session will discuss how strong coverage analysis processes can improve study start-up, reduce compliance risk, support accurate billing, and foster communication across research teams, finance, and operations. Attendees will hear real-world lessons learned about common challenges faced by organizations and practical ways to improve efficiency, consistency, and collaboration. The presentation will highlight how coverage analysis can move beyond a transactional process and become a key part of building stronger, more sustainable clinical research programs.

CEU: 1.0 ACRP

Speaker:

• Nishat Premani, Manager, Huron Consulting Group

As site management organizations (SMOs) continue to expand, many face a common challenge: inconsistent start-up processes, variable staff training, and operational inefficiencies that delay study activation and enrollment. While budgets and contracts are often viewed separately from site operations, successful study execution depends on alignment between start-up, onboarding, and operational workflows.

This session will explore how standardized start-up processes, structured training programs, and cross-functional collaboration can improve study activation timelines, reduce costly rework, and create more consistent outcomes across multiple research sites. Through real-world examples and audience discussion, attendees will learn practical strategies to connect contracts, budgets, start-up activities, and workforce development into a scalable operational framework. Attendees will leave with actionable tools to improve efficiency, strengthen site performance, and support sustainable growth within single-site organizations and multisite research networks.

CEU: 1.0 ACRP

Speakers:

• Kayleen Murphy, Training and Education Lead, Innovo Research

• Brittany Regler, MHA, Senior Manager of Revenue Operations, Innovo Research

A four-person panel representing clinical research administration, project management, study coordination, and health system-based clinical teams will highlight a real-world case example of integrating neurodiagnostic clinical staff into clinical research operations. The panelists will discuss challenges posed by the operational disconnect between clinical research teams and clinical staff and share engagement strategies, training initiatives, and collaborative workflow designs utilized to successfully initiate and conduct high-quality clinical research in collaboration with clinical staff. They will also discuss integrating clinical research into clinical care settings without disrupting patient care delivery services and the resulting cultural and operational benefits observed.

CEU: 1.0 ACRP

Speakers:

• Susan Beymer, MSML, HCS Operational Project Manager / Study Coordinator, UNC Health

• Kerry Finch, MSCRM, BSN, RN, CCRP, Assistant Professor, Campbell University

• Alexandra Gropp, R. EEG T, BA, Neurodiagnostic Coordinator, UNC Health Rex

• Summer Lawrence, MPH, HCS Operational Project Manager / Study Coordinator, UNC Health

Clinical trial sites, sponsors, and contract research organizations continue to face delays and inconsistencies in coverage analysis, budget development, visit-level cost review, and reimbursement negotiations. As protocols become increasingly complex, manual processes can lead to misaligned expectations, delayed study start-up, billing compliance risk, under-reimbursed site work, and inefficient sponsor-site communication.

Through a case-based framework, this session will examine how artificial intelligence (AI)-enabled technology can support more consistent, transparent, and efficient clinical trial budgeting and coverage analysis workflows, for example by assisting with protocol and schedule-of-activities review, procedure identification, sponsor-paid versus routine-care logic, and documentation support.

The session will also address where human oversight remains essential, demonstrating that AI is not a replacement for clinical research professionals.

CEU: 1.0 ACRP

Speaker:

• Tia Warrick, Chief Executive Officer, Lesous Consulting LLC

As the demand for clinical trials involving advanced and complex therapies continues to expand, many site networks struggle to scale effectively while maintaining quality, operational consistency, and patient access.

This session will address how traditional network expansion models often prioritize site volume over infrastructure maturity and propose strategies for tackling the resulting challenges in study start-up, oversight, execution, and scalability in terms of the operational foundations required to build high-performing site networks capable of supporting advanced therapeutic trials, including rare disease and gene therapy programs. Attendees will examine real-world approaches to strengthening governance, standardizing operational workflows, enhancing site readiness, and balancing centralized oversight with local site flexibility.

Attendees will leave with actionable approaches to strengthen network performance, reduce operational variability, and scale advanced therapy programs more effectively.

CEU: 1.0 ACRP

Speaker:

• Rachana Kanvinde, MS, SFC, CCRP, Director, SPARK CoE, Clinical Trial Access & Partnerships, Tigerlily Foundation

Break for lunch and make the most of your time together—connect with your community, reflect on your key takeaways, and continue charting your course with insights and connections to carry forward.

This session will review ethical and regulatory protections for vulnerable populations in human subjects research, with an emphasis on differences between pediatric and adult participants. Topics will include definitions of vulnerability, informed consent, assent, surrogate decision-making, and risk-benefit assessment. Also discussed will be practical approaches to evaluating adults participants' decision-making capacity, while pediatric-specific issues, such as developmental capacity, parental permission, and minimal-risk standards, will be compared to challenges in adult vulnerable populations, including cognitive impairment, critical illness, and socioeconomic barriers.

The session will also address emergency research, deferred consent, and equity in recruitment. Interactive case discussions will help participants apply ethical principles and practical strategies to strengthen participant protection and research integrity.

CEU: 1.0 ACRP

Speakers:

• Elena Alferova, Clinical Research Regulatory Coordinator, UCSD Moores Cancer Center

• Muhammad Waseem, MD, MS, Research Director, Emergency Medicine, Lincoln Medical Center, Bronx New York

Clinical trial protocols remain largely static documents, requiring research sites to manually interpret, translate, and re-enter protocol details across systems and workflows. This creates duplication, delays, and variability in downstream activities such as clinical trial management system calendar builds, Medicare coverage analysis, budget development, contract review, and patient outreach configuration. This session will explore how digital data standards and digitization methods can help convert protocol content into structured, machine-readable data that support more standardized, efficient, and reusable site workflows. Panelists will discuss emerging standards, sponsor and contract research organization adoption considerations, and the practical implications of moving to data-driven protocol execution. Using site-centered operational examples, the session will examine where digital protocols can reduce manual effort, improve consistency, and support faster study activation. Attendees will leave with practical considerations for evaluating digital protocol readiness and identifying workflows that may benefit from structured protocol data.

Using site-centered operational examples, the session will examine where digital protocols can reduce manual effort, improve consistency, and support faster study activation. Attendees will leave with practical considerations for evaluating digital protocol readiness and identifying workflows that may benefit from structured protocol data.

CEU: 1.0 ACRP

Speakers:

• Bill Illis, Workstream Leader, Digital Data Flow (Protocol Digitalization), TransCelerate BioPharma Inc.

• James Wurdeman, SVP Product Lead, Advarra

As the International Council for Harmonization (ICH) E6(R3) guideline for Good Clinical Practice redefines clinical research through Quality by Design and risk-based approaches, traditional research staff training models must evolve to prepare a workforce capable of applying these principles in real-world settings. This requires innovative, practice-driven training that aligns with regulatory expectations. Thus, this panel explores how artificial intelligence (AI)-enabled simulation enhances onboarding, continuing education, and academic preparation by bridging theory and real-world application while reinforcing key principles outlined in ICH E6(R3).

Panelists will share practical methods for designing and implementing immersive simulations in both in-person and virtual environments targeting such areas as informed consent, medical history assessment, and culturally responsive communication.

Attendees will gain actionable strategies to create engaging learning experiences that integrate feedback, reflection, and structured debriefing to strengthen critical thinking, confidence, regulatory readiness, and participant-centered practices to modernize training. 

CEU: 1.0 ACRP

Speakers:

• Meredith Fitz-Gerald, MSN, FACT, Director of Community Partners and Education, UAB School of Medicine

• Carolynn Jones, DNP, MSPH, CRN-BC, FAAN, Professor, Coordinator, Clinical Research Management Certificate and MSN CRM, University of Alabama at Birmingham, School of Nursing

• Kimberly McCall, PhD, MPA, EdS, Assistant Professor, University of Alabama at Birmingham

Clinical trial sites are measured constantly, but they’re often evaluated through performance data they cannot fully see, contextualize, or use in real time. This interactive presentation reframes site metrics as shared operational signals that can support earlier intervention, fairer interpretation, and stronger study execution.

Using real-life examples, the presenters will examine how sponsors, contract research organizations, and sites can distinguish lagging indicators from leading indicators and reduce the data asymmetry that can limit site action.

Attendees will explore and gain practical strategies on how commonly tracked measures—including enrollment progress, screen failure patterns, protocol deviations, data entry timeliness, and query resolution—can be interpreted with appropriate context and used collaboratively during trial conduct.

CEU: 1.0 ACRP

Speaker:

• Christine Senn, PhD, FACRP, CCRC, CPI, SVP, Site-Sponsor Innovation, Advarra

For clinical research professionals, 2026 was not an abstract policy year. It was a year of real operational disruption, genuine scientific debate, and an uncomfortable truth: the regulatory environment is moving faster than the abilities of most organizations to adapt.

Five developments defined it. The U.S. Food and Drug Administration (FDA) ended the two-trial standard that had anchored drug development since the 1960s. The FDA's Real-Time Clinical Trials initiative moved from concept to proof of concept. National Institutes of Health funding disruptions terminated hundreds of trials, affecting tens of thousands of enrolled participants and causing lasting damage to academic research infrastructure. FDA workforce reductions created genuine review capacity constraints that are still affecting Investigational New Drug timelines and early protocol feedback. And the shift from mandated diversity action plans to voluntary reporting left organizations without clear guidance on what compliance actually requires now.

Attendees of this session will leave with a practical framework for operating confidently inside each of these changes and a clearer view of where the ambiguity still lives.

CEU: 1.0 ACRP

Speakers:

• Catherine Gregor, Chief Clinical Trial Officer, Florence Healthcare

• Sophia McLeod, Director, Government Relations, ACRO

As clinical research becomes increasingly global and operationally complex, academic medical centers are assuming expanded roles as sponsors, coordinating centers, and innovation hubs for multinational clinical trials. This panel session will explore how the Dominantly Inherited Alzheimer Network (DIAN) program, an international academic-led research consortium focused on autosomal-dominant Alzheimer’s disease, has developed and sustained a scalable infrastructure supporting global observational studies, registries, and therapeutic trials.

Attendees will learn how DIAN integrates centralized operational oversight, participant-centered engagement, data harmonization, and cross-sector collaboration across academia, industry, advocacy organizations, and international research sites. Practical operational lessons related to study start-up, global coordination, data integration, regulatory considerations, and long-term participant retention will be discussed. The session will highlight how academic-based models can accelerate translational science while supporting high-quality, compliant global research operations in rare and complex diseases.

CEU: 1.0 ACRP

Speakers:

• Jamie Bartzel, Clinical Research Coordinator, Washington University in St. Louis

• Stephanie Belyew, MS, Associate Director, Research Clinical Trials Operations, Washington University in St. Louis

• Alisha Daniels, MD, MHA, CCRC, ACRP-PM, Executive Director/Assistant Professor, Washington University in St. Louis

• Susan Mills, Senior Director, Clinical Operations, Washington University in St. Louis

• Ellen Ziegemeier, MA, Clinical Research Specialist, Washington University in St. Louis

Precision oncology referrals often begin with a promising molecular match, but a matched trial record does not guarantee practical access. Patients with advanced cancer may need external trial options more than once, and coordinators may become key navigators across institutions, records, eligibility questions, slot availability, waitlists, and travel decisions. This session examines the operational gap between trial identification and trial access, including the role of first-contact staff. Attendees will learn how coordinators can support external trial navigation while avoiding overpromising, protecting patients from avoidable burden, and keeping treating providers informed. Pre-travel feasibility review, role-aware intake communication, escalation pathways, patient counseling, referral templates, and feasibility checklists will be addressed. Participants will leave with a replicable framework for distinguishing exploratory consultations from actionable trial pathways.

CEU: 1.0 ACRP

Speakers:

• Joshua Cook, M.S. (Data Science), M.S. (Clinical Research Management), ACRP-PM, CCRC, Clinical Research Coordinator; Adjunct Instructor

  Florida Cancer Specialists & Research Institute (Woodlands Davis Office); University of West Florida

• Jessica McCullagh, Clinical Research Trainer, Florida Cancer Specialists & Research Institute

Clinical research coordinators (CRCs) are the backbone of clinical trials, yet their voices are rarely centered in workforce-related discussions. Given ongoing turnover trends and increasing job complexity, CRC-specific workforce data are urgently needed to inform sustainable staffing models.

This session highlights survey findings from more than 3,000 CRCs across diverse clinical research settings, offering one of the largest CRC-focused datasets to date. Using validated instruments that enable comparison with prior studies, the presenters will explore what CRCs reported about workload, recognition, career pathways, and retention. While some variations exist across settings, core patterns were consistently observed. By examining these findings through a cross-national lens, this session offers insights that highlight shared workforce challenges.

Attendees will leave with evidence-informed strategies that they can implement immediately to strengthen CRC retention and build more sustainable research teams.

CEU: 1.0 ACRP

Speakers:

• Toshiko Ishibashi, Chief of Staff, Daiichi Sankyo Co., Ltd.

• Edwina McNeill Simaan, Program Director, Vanderbilt University Medical Center