When you arrive in Orlando, make your way to the registration desk (Convention Level) to receive your conference badge and essential materials, ensuring you're fully equipped for ACRP 2026.
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 with a delicious breakfast and engaging conversations—connect with 50+ innovative organizations driving better results in clinical research.
Signature Series Session
Clinical research is a dynamic field involving complex policies and processes whose planning, conduct, and oversight are shaped by people at every stage of their professional journey. This panel brings together diverse voices—from early-career professionals to seasoned leaders—to share their unique career paths, the leadership skills that helped them grow, and the pivotal moments that shaped their trajectories.
Panelists will offer insights into entering and evolving within the clinical research space; the leadership competencies that make a tangible difference; lessons learned for those forging their own path; and what keeps them motivated in this ever-changing field. Whether you're navigating your first role or mentoring the next generation, this conversation will impart valuable perspectives into the leadership, resilience, and passion that drive success in clinical research. You’ll leave with a renewed motivation to shape your own path, contribute with purpose, and stay inspired in a field that’s always evolving.
CEU: 1.00 ACRP
Speaker:
Muriel Maignan Wilkins, CEO & Founder, Paravis Partners
Perk up with a shot of caffeine and a splash of conversation—don’t miss this 15-minute recharge in the Expo Hall!
This session explores a real-world case study from an interventional oncology trial to demonstrate how informed consent can be ethically and systematically optimized for vulnerable participants with impaired decision-making capacity. Attendees will examine how regulatory requirements and institutional safeguards can be integrated into a practical framework that ensures participant protection while supporting trial enrollment. Through a step-by-step analysis, we will cover patient eligibility verification, capacity assessment, legally authorized representatives, and documentation practices. The session offers a reproducible and proactive framework for how early planning, use of validated tools, and adherence to institutional review board guidance can support ethical trial conduct involving vulnerable populations.
CEU: 1.00 ACRP
Speaker:
Elena Alferova, Clinical Research Regulatory Coordinator II, UCSD Moores Cancer Center
Watch a Sneak Peek into the Session Content:
As clinical research embraces digital transformation, generative artificial intelligence (AI) stands out as both a powerful and often misunderstood tool. This session—led by a clinical operations consultant with more than 17 years of contract research organization and pharmaceutical firm experience—offers a grounded look at how AI is reshaping operational workflows. Drawing from real-world examples, the session outlines a phased, risk-aware approach to AI implementation. Attendees will gain practical strategies for applying AI in feasibility, site communications, document authoring, risk-based monitoring, testing scripts, and data cleaning—while safeguarding data integrity and compliance. Designed for clinical trial professionals seeking actionable guidance—not hype—this session's emphasis is on starting small, building trust, and ensuring AI supports science and patients alike.
CEU: 1.00 ACRP
Speaker:
Michael Thomas, Clinical Operations Consultant, MT Clinical Consulting
Clinical research is often seen as a risk-averse industry, but is that perception accurate? This interactive session challenges the assumption that traditional choices are inherently safe. Through real-world case studies and a behavioral risk framework, we’ll explore how decisions around protocol design, site selection, technology adoption, and feasibility often mask high operational risk under the guise of caution. Attendees will examine how “playing it safe” can lead to protocol amendments, recruitment failures, and delays, and learn how to use Quality by Design (QbD) and ICH E8(R1) principles to anticipate and mitigate these outcomes. The session includes audience polling, risk-mapping exercises, and practical tools to identify where organizations may be unintentionally risk-seeking. Whether you’re in study startup, clinical operations, or site management, you’ll walk away with actionable strategies to reframe risk, support better decision-making, and challenge the illusion of safety that drives costly inefficiencies in clinical trials.
CEU: 1.00 ACRP
Speakers:
Mitchell Hilbe, CEO / Co-Founder, DiversiTrials
Jess Thompson, CEO, Clinical Research Pro
Jami Walker, Clinical Operations and Management, Mead Johnson
Federally Qualified Health Centers (FQHCs) are nonprofit organizations governed by patients that provide high-quality, comprehensive healthcare to medically underserved populations across the United States, regardless of income or insurance coverage. In 2023, FQHCs served 32.5 million patients, with 63% identifying as people of color. In North Carolina specifically, FQHCs serve more than 750,000 patients annually, with more than 60% of them being people of color. Despite this broad reach and impact, FQHCs remain an underutilized resource in clinical research. This session will explore how FQHCs can serve as decentralized clinical trial sites to expand access and address long-standing disparities in trial participation. The session will highlight insights from surveys and questionnaires completed by patients and FQHC care teams, share best practices for integrating clinical trials, and discuss the necessary infrastructure to support research within FQHCs.
CEU: 1.00 ACRP
Speaker:
Rebecca Hayes, MD, MEHP, Director of Research, North Carolina Community Health Center Association
Korrey Monroe, MPH, Research Program Manager, North Carolina Community Health Center Association
Mayra Overstreet Galeano, Chief Medical Officer, Community Faculty, Adjunct Assistant Professor, MedNorth Health Center, Novant Health, University of North Carolina at Chapel Hill
Peter Shin, PhD, MPH, Chief Science Officer, National Association of Community Health Centers
Whether you're early in your career or a seasoned professional, it’s easy to confuse “doing good work” with “communicating your value.” This session offers practical tools to help you tell your professional story with clarity and purpose—on paper, online, or in conversation. Through guided reflection, real-world examples, and structured templates, you will learn to draft an authentic elevator pitch, apply the STAR (Situation, Task, Action, Result) method to describe outcomes, translate daily work into impactful résumé content, and outline a personal career communication plan with specific actions to build visibility over the next 30 days. Beyond the job-seeking context, the focus is on ongoing visibility and confidence—whether you are looking to grow, pivot, or lead from where you are. Advancement isn’t just about upward mobility—it’s about alignment with your goals. This session delivers usable tools to help you own your narrative and support career development in any direction.
CEU: 1.00 ACRP
Speaker:
Leslie Sam, BA, CSSBB, CQIA, President, Leslie Sam and Associates, LLC
As clinical research grow more complex and data-driven, patient-centered risk management is essential to designing resilient trials. This panel explores a holistic, ICH E6(R3)-aligned approach that embeds risk mitigation across the trial lifecycle while prioritizing patient needs, safety, and experience. Panelists will share real-world examples of how inclusive protocol design and patient advisory input during early planning reduce risk by improving accessibility, engagement, and retention. In startup, automated site selection and harmonized regulatory workflows minimize delays and variability, accelerating patient access. Artificial intelligence-based image sharing and interpretation require validated, explainable models and human oversight as key risk mitigation strategies to safeguard outcomes. Predictive analytics, risk-based monitoring, and centralized oversight tools help identify early warning signals and enable timely intervention. By embedding holistic risk mitigation with patient-centered operational strategies, innovation, and oversight, this session highlights how to build trials that are not only compliant and efficient, but also resilient and responsive.
CEU: 1.00 ACRP
Speakers:
Lourdes Carhuapoma, PhD, CRNP, Director, Participant-Centered Research Integrity and Risk, Johns Hopkins University, BIOS Clinical Trials Coordinating Center
Lindsay Eyzaguirre, MS, Assistant Professor, Johns Hopkins University School of Medicine; Clinical Coordinating Center Director, BIOS CTCC; Project Lead, Johns Hopkins University Trial Innovation Center (JHU TIC), Johns Hopkins University, BIOS Clinical Trials Coordinating Center
Karen Lane, CCRP, Assistant Professor of Neurology, Johns Hopkins University Deputy Director, BIOS Clinical Trials Coordinating Center Director, Multicenter Study Operations Training Program, ICTR MPI, Johns Hopkins University Trial Innovation Center, Johns Hopkins University, BIOS Clinical Trials Coordinating Center
Andrew Mould, MPH, Assistant Professor, Department of Neurology; Data Coordinating Center Director, BIOS CTCC; HEAL Director, JHU SSRC HEAL Pain ERN; Assistant Director, Johns Hopkins University Trial Innovation Center, Johns Hopkins University, BIOS Clinical Trials Coordinating Center
Transform your workplace culture through proven strategies that build genuine employee engagement, trust, and accountability. This session focuses on creating a thriving organizational environment where employees feel valued, connected, and motivated to contribute their best work. Participants will learn to establish trust as the foundation of engagement through transparency and consistent leadership behaviors. The session features the innovative ALIGN method for collaborative goal setting, enabling teams to create shared objectives that drive organizational success. Discover how to shift from traditional performance reviews to growth-focused evaluation conversations that inspire development rather than judgment. Learn to implement positive accountability systems that support employees while building trust. Key topics include positive workplace habits, open communication channels, transparent progress tracking, and sustainable cultural change through continuous feedback and recognition. Attendees will leave with practical frameworks and actionable strategies to immediately transform their workplace culture.
CEU: 1.00 ACRP
Speaker:
Leslie Pimentel-Byatt, MSML, MBA, CCRC, PMP, Director, Clinical Trials Operations, University of New Mexico Hospital
Too few research organizations (e.g., sponsors and sites) have access to the large and diverse populations that primary care organizations (PCOs) and their healthcare professionals serve. This session will bring forth the results and easy-to-use, action-oriented tactics from the first-of-its-kind “Research in Primary Care Action Roundtable,” which included participants from PCOs, study sponsors, and study sites. PCOs are a healthcare entity focused on delivering first-contact, comprehensive, and continuous care to individuals and families across all ages, genders, and health conditions. They care for more than 100 million people in the United States, yet clinical trial access and participation through them continue to be seen at minimal levels. A shared vision is to build a movement to make clinical trials mainstream in support of healthcare’s pivot toward value-based care, and to provide research organizations with access to large and diverse populations leading to more efficient, representative, and accelerated study enrollment.
CEU: 1.00 ACRP
Speakers:
Ruma Bhagat, MD, MPH, Senior Director, Health Equity & Population Science, Genentech
Osa Eisele, MD, MPH, Executive Director and Head of Representation in Clinical Research, Amgen
Pete Fronte, MBA, President & CEO, Altura'
Rakesh Patel, MD, MBA, FACHE, CPE, CEO, Neighborhood Healthcare
Engaging vulnerable populations in research requires careful consideration of ethical and practical challenges. Researchers must prioritize participants' safety, privacy, and well-being while ensuring the research is meaningful and impactful for the community. This presentation will highlight real-world experiences, challenges, and practical solutions for involving vulnerable populations in research during trying times such as those we face now.
It's important to emphasize that additional protections should not deter researchers from involving these groups. Instead, such safeguards enable ethical inclusion, ensuring that individuals who may benefit most from research are not systematically excluded due to perceived risks or complexities.
CEU: 1.00 ACRP
Speaker:
Muhammad Waseem, MD, MS, Research Director, Emergency Medicine, Lincoln Medical Center
Related Blog Content
How does a site know that a sponsor's medical device and study design will generate appropriate scientific evidence to justify or require a clinical trial? Sites may already be familiar with the sponsor and investigator responsibilities for Investigational Device Exemption (IDE) studies outlined in 21 CFR 812 of the Code of Federal Regulations, but this session will provide a tutorial on the regulatory expectations for IDE application submission or a non-significant risk (NSR) determination before initiating device clinical trials. The content will cover IDE applications and the documents that will be reviewed by the U.S. Food and Drug Administration before approving an IDE and how an NSR determination translates to abbreviated 21 CFR 812 requirements. Also discussed will be design controls to ensure a medical device is clinically ready for a clinical trial and how they still apply to NSR device studies including in vitro diagnostic products.
CEU: 1.00 ACRP
Speaker:
Wendy Schroeder, Principal Strategy Consultant, Clinical, NAMSA
As the University of Alabama at Birmingham's Clinical Research Support Enterprise (CReSt) expanded, traditional systems proved insufficient for managing the growing complexity of clinical trial operations. Determining trial costs became a focus, with a goal of implementing no-cost, scalable solutions that improved visibility across the trial lifecycle, empowered staff, and could be replicated by other institutions. The CReSt unit adopted a suite of open-source tools to develop platforms for managing such core trial functions as study startup, enrollment tracking, subject reimbursements, and automated reporting. These tools were created entirely by clinical research administrators without the support of an information technology team or professional developers. Crucially, generative artificial intelligence (AI) tools were used to build, debug, and refine these systems. These tools accelerated development and lowered the technical barrier for non-programmers to build impactful solutions.
CEU: 1.00 ACRP
Speaker:
Meredith Fitz-Gerald, RN, MSN, Clinical Research Support Enterprise Director - Education and Clinical Outreach, The University of Alabama at Birmingham
Bringing a novel implantable device from concept to human trials is daunting—doing it entirely within an academic setting, without commercial sponsorship, is almost unheard of. Our team successfully navigated the full translational pipeline: developing the device and treatment protocol, conducting rigorous preclinical testing, securing U.S. Food and Drug Administration (FDA) Investigational Device Exemption approval, and executing an early feasibility study, ultimately culminating in a Nature publication. This session provides a practical framework for managing operational complexity in sponsor-investigator trials. We will share actionable strategies for communication, regulatory preparedness, role delineation, and risk mitigation—focusing on the tools and practices that allowed our team to proceed with confidence. For academic institutions, startups, or research teams operating at the edge of innovation, this session offers grounded, replicable strategies for moving from concept to clinic—and highlights the operational systems we would never do without.
CEU: 1.00 ACRP
Speaker:
Amy Porter, PE, MBA, Director, Texas Biomedical Device Center at the University of Texas at Dallas
Step into an exclusive gathering of 300 directors, managers, and executives who are shaping the future of clinical operations. Hosted in the stunning Hyatt Regency Rotunda on Saturday, April 25, 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 discuss what’s next—connect with your community, share your top takeaways with your peers, and discover solutions from 50+ trailblazing organizations throughout the Expo Hall.
This presentation will discuss the experience and process of building a quality assurance/quality improvement (QA/QI) program from the ground up following the merger of two large health systems across geographical distances. It will discuss where to begin, considerations when designing services, operationalization, the importance of including stakeholders, and lessons and pitfalls learned through real-world experiences.
CEU: 1.00 ACRP
Speakers:
Sarandeep Kaur, MS, CCRC, Research Accountability Specialist, Corewell Health
Karen Sherer, Director, Research QA/QI, Corewell Health
Laura Stuecher, RN, BSN, CCRP, QA/QI Research Specialist, Corewell Health
This session will delve into how sponsors develop effective recruitment strategies for clinical trials, emphasizing the practical impact of these tactics. Attendees will gain insights into how feedback from clinical sites is utilized by sponsors to craft creative and adaptive recruitment approaches. The session will highlight real-world examples and case studies to illustrate the success of these strategies in enhancing participant engagement and trial efficiency.
CEU: 1.00 ACRP
Speakers:
Simranjit Mehta, Recruitment Strategist, Pfizer
Nikki Thomas, Recruitment Strategist, Pfizer
The clinical research workforce is facing growing challenges, especially in the recruitment and retention of research nurse coordinators. This session will highlight an innovative collaboration between a clinical research team and a bachelor of science in nursing program aimed at introducing nursing students to clinical research as a meaningful and dynamic career option. By engaging future nurses early in their education, this partnership helps bridge the gap between clinical care and research, building awareness, interest, and preparedness among new graduates. Attendees will hear how this model not only expands the pipeline of qualified professionals but also enhances the visibility and value of the research nurse coordinator role within healthcare. The presenters will share insights, lessons learned, and steps for developing similar collaborations with nursing schools. This forward-thinking approach has the potential to significantly strengthen the clinical research workforce and ensure a more sustainable, informed, and engaged generation of research-ready nurses.
CEU: 1.00 ACRP
Speakers:
Lauren Hasty, Clinical Research Nurse, St Jude Children's Research Hospital
Jamie Russell, Manager- Clinical Research Management, St Jude Children's Research Hospital
Related Blog Content:
This dynamic session explores the complexities and opportunities of conducting clinical research outside the United States. Through real-time polling, interactive Q&A, and scenario-based reflection, attendees will gain practical insights into regulatory, cultural, and operational differences across global regions. The session will equip clinical research professionals with tools and strategies to confidently engage in multinational trials, while promoting inclusion, equity, and global collaboration.
CEU: 1.00 ACRP
Speaker:
Katherine Mary Marangio, MSc, Learning Program Consultant, Parexel Academy
Watch a Sneak Peek into the Session Content:
This highly interactive session will introduce participants to an innovative, multiculturally aware approach for advancing equitable and inclusive representation in clinical trials. We will share our journey in developing and piloting a novel engagement model, highlighting both the community-engaged design process and early findings from our pilot implementation. Participants will then engage in a hands-on activity that maps key inclusivity-driven strategies and frameworks from our model to their own work. By the end of the session, attendees will leave with practical, actionable tools to advance equity and racial justice in their clinical trial recruitment efforts.
CEU: 1.00 ACRP
Speakers:
Chaya Pflugeisen, MSc, MEd, Manager, Investigator Initiated Research, MultiCare Health System
Deana Williams, PhD, MPH, Research Investigator, MultiCare Health System
Take a breather and make meaningful connections—mingle with exhibitors and colleagues in the Expo Hall during this afternoon networking break.
Artificial intelligence (AI) is revolutionizing clinical research by enhancing protocol generation, operational efficiency, and participant recruitment/engagement. Through predictive analytics and digital twins, AI streamlines protocols, optimizes inclusion criteria, and minimizes risk. AI also strengthens safety monitoring by identifying early adverse event patterns across diverse datasets, enabling proactive responses. For sponsors and sites, AI supports ongoing access to training and streamlines standard operating procedure development by analyzing past performance and recommending standardized practices. It automates data collection, reducing manual errors and accelerating timelines. In recruitment, machine learning matches ideal candidates using electronic health records and real-world data, while adaptive algorithms personalize recruiting messaging to improve enrollment rates. Together, these innovations reshape the trial landscape, making studies faster, safer, and more inclusive without compromising data integrity or participant protection. Examples reviewed include seen and unseen real-world AI impacts.
CEU: 1.00 ACRP
Speakers:
Alain Alvarez Legra, Director for Clinical Research Coordinators, Bolanos Clinical Research
Karen Lindsley, DNP, MSN, RN, CCRC, CDCES, Manager of Regulatory Knowledge and Support, Clinical and Translational Science Alliance of Georgia, Emory University
In a rapidly evolving clinical research landscape, effective leadership is more crucial than ever for driving collaboration, innovation, and trust among academic centers, site management organizations, and technology partners. This dynamic session will introduce the “Four Cs” leadership framework—character, competence, caring, and communication—adapted for today’s complex research environment. Three seasoned leaders with varied backgrounds will share insights on how leadership philosophies must adapt to varying organizational cultures, regulatory demands, and operational realities. Attendees will explore practical strategies to cultivate leadership capacity, manage resource constraints, and prevent burnout while promoting ethical and patient-centered research. Real-world stories will illuminate challenges and solutions in building and sustaining successful collaborations among sites, sponsors, contract research organizations, and academia. The session encourages interactive discussion, equipping attendees with actionable tools to strengthen their own leadership impact and foster high-performing, resilient research partnerships.
CEU: 1.00 ACRP
Speakers:
Christina Brennan, MD, MBA, CCRC, FACRP, Senior Vice President, Clinical Research, Northwell Health
Elisa Cascade, MBA, FACRP, Chief Growth Officer, Head of Americas, TrialScreen
Christine Senn, PhD, CCRC, CPI, FACRP, SVP, Site-Sponsor Innovation, Advarra
In 2025, the U.S. Department of Health and Human Services (HHS) initiated several significant policy changes impacting how clinical trials are conducted in the U.S. This session will explore five major developments: updated informed consent standards prioritizing plain language and accessibility; new HHS-led interoperability efforts to streamline trial data exchange; clarified Internal Revenue Service guidance on taxing participant stipends; a shift from mandated diversity action plans to a voluntary reporting framework; and cross-agency modernization efforts through the HHS Clinical Trials Modernization Working Group. These changes—while intended to promote transparency and innovation—have introduced ambiguity for sites, sponsors, and contract research organizations. Attendees will gain clarity on how to operationalize these updates, navigate compliance challenges, and align processes with the evolving federal landscape in 2026 and beyond.
CEU: 1.00 ACRP
Speakers:
Catherine Gregor, MBA, CCRP, CCRC, Chief Clinical Trial Officer, Florence Healthcare
Sophia McLeod, Advocacy Advisor, Association of Clinical Research Organizations (ACRO)
Strong collaboration between contract research organizations (CROs) and study sites is essential for reducing trial delays, improving data quality, and accelerating patient access to new therapies. This panel, designed for clinical research professionals in operations, monitoring, study startup, and site roles, explores how intentional collaboration between CROs and study sites can drive measurable improvements in operational efficiency and data quality. Panelists will share real-life case studies and practical examples that highlight strategies for streamlining study startup, reducing rework, and building trust. Attendees will gain forward-thinking insights and walk away with actionable tips, tools, and processes to strengthen site-CRO relationships and enhance trial success. Join us to explore how shifting from reactive problem-solving to proactive partnership can transform site-CRO relationships into high-impact alliances that advance research and patient care.
CEU: 1.00 ACRP
Speakers:
Elizabeth Feathers, Clinical Operations Supervisor, Study Startup, CIBMTR
Alisha Mussetter, Clinical Operations Manager, CIBMTR
Kassandra Nealon, BS, Senior Training & Development Specialist – Clinical Monitoring, CIBMTR
Artificial intelligence (AI) is transforming clinical research by streamlining patient identification, automating data capture, and enhancing imaging analysis. This session explores practical applications of AI in oncology trials, focusing on three high-impact areas: 1) patient matching and identification using advanced algorithms to accelerate enrollment and improve diversity; 2) seamless data collection through integration from electronic medical records to electronic data capture, reducing manual errors and increasing efficiency; and 3) automated imaging analysis, such as AI-driven RECIST measurements, to improve consistency and speed in response assessments. Attendees will take away actionable insights and learn from real-world examples for implementing AI solutions while addressing challenges in adoption, data quality, and regulatory considerations.
CEU: 1.00 ACRP
Speaker:
Chelsea Osterman, MD, Senior Medical Director, Tempus AI
The session is designed to open the door to a live reinactment of an institutional review board (IRB) meeting that includes samples of the the most sensitive and controverted decisions facing IRBs today. The purpose is to inform researchers of the inner workings and, more importantly, the often intense deliberations arising from today's clinical trial proposals and reports as the panel reconciles regulatory mandates and ethical principles with modern research conundrums. The 30-minute, mock IRB meeting will include a protocol, amendment, report of noncompliance, and continuing review followed by a 15-minute Q&A opportunity.
CEU: 1.00 ACRP
Speaker:
Robert Romanchuk, CIP, BSHS, Chairperson, Regulatory Director, Univo IRB
