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