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