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
Speakers coming soon!
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
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
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
Shannon Hillery, Manager, Accelerated Start-Up Unit, 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
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
Speakers:
Meredith Fitz-Gerald, RN, MSN, Clinical Research Support Enterprise Director - Education and Clinical Outreach, The University of Alabama at Birmingham'
Patrick Frazier, RN, Clinical Research Support Enterprise Director of Systems and Compliance, 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
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
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
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
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
Clinical expertise has a clearly defined role and purpose in clinical research from randomizing treatments to managing adverse events to monitoring the overall health of participants. However, scientific expertise seems to be expected only from those who design studies, analyze final datasets, and manage the investigational products in question. This increases a sense of separation between sponsors and sites that results in clinical trial operations being considered mostly in terms of financial transactions. At the site level, a similar divide in research staff often occurs as the study coordinators understand the study mechanics and the medical clinicians understand the disease, often causing friction in operations and staff turnover. By developing a novel clinical research model, our team has addressed these gaps and witnessed improvements in staff recruitment and retention as well as decreases in detrimental protocol deviations. This model includes a clear career development pathway for clinical research professionals.
CEU: 1.00 ACRP
Speaker:
Lacey Andrews, MS, CCRC, CCRA, Lead Clinical Research Coordinator, Marshall University's Joan C. Edwards School of Medicine, Department of Family and Community Health
Todd Davies, PhD, Associate Director of Research, Marshall Health
The clinical research industry offers a variety of career pathways, yet many site-based professionals struggle to transition to roles within contract research organizations or sponsor settings. This session will outline the skills, experiences, and strategic positioning needed to make that leap successfully. Drawing from real-world examples, panel insights, and current hiring trends, we’ll explore how site-based coordinators, managers, and research staff can translate their operational expertise into qualifications for project management, clinical research associate, medical affairs, regulatory affairs, and other sponsor-side roles. Attendees will leave with a roadmap, tools for self-assessment, and strategies to proactively align their current responsibilities with future goals.
CEU: 1.00 ACRP
Speaker:
Tamika Harris, Clinical Operations Manager - Regulatory, Merck
Jessica Propps, ACRP-CP, Clinical Operations Manager - Regulatory, Merck
This interactive presentation guides participants through applying proven project management principles across all scales of work, from organizational initiatives to everyday task management. Attendees will learn to leverage essential project management tools including strategic planning frameworks, effective scheduling techniques, Gantt chart creation and interpretation, and dependency mapping to optimize workflow and productivity. Through practical examples and hands-on exercises, participants will discover how to break down complex projects into manageable components, identify critical path dependencies, and create realistic timelines that account for resource constraints and competing priorities. The session will demonstrate how the same methodologies that drive successful large-scale initiatives can transform daily task management, reducing stress and increasing efficiency.
CEU: 1.00 ACRP
Speaker:
Leslie Pimentel-Byatt, MSML, MBA, CCRC, PMP, Director, Clinical Trials Operations, University of New Mexico Hospital
Connect with your colleagues and 50+ leading-edge organizations and suppliers helping you get better results in clinical research.
Relax and unwind with a beverage and light hors d'oeuvres in the Expo Hall.
Clinical research professionals are used to calling the shots, running the protocols, and making sure everything operates smoothly during trials. But have you ever wondered what it's like to be on the other side of the clipboard? This session turn the tables so that attendees can hear from seasoned professionals who have stepped into clinical research participant role. Join us for a lively discussion as our panelists share their experiences and insights, revealing how being a participant has shaped their approach to research.
CEU: 1.00 ACRP
Speakers:
Bishoy Anastasi, Senior Director, Clinical Research Finance & Strategy, UCLA School of Medicine
Bree Burks, RN, MSN, Vice President of Strategy, Veeva Systems
Meredith Fitz-Gerald, RN, MSN, Director-Clinical Research Support Program, The University of Alabama at Birmingham
Mark Marchant, MBA, MPH, CCRP, Executive Director-Clinical Trials Administrative Office, The University of Alabama at Birmingham
Brian Sevier, PhD, Chief Operations Officer-Yale Center for Clinical Investigation, Yale University
Laura Viera,, MS, CCRP, Director-Clinical Research Operations, University of North Carolina
Watch a Sneak Peek into the Session Content:
Leadership & Professionalism Journey Sponsor
This presentation will consider the regulatory, operational, and ethical facets of collecting genetic information for clinical research. Topics covered will include regulations surrounding genetic testing and return of results; optimizing protocol design to facilitate specific genetic testing while reducing unnecessary collection; and considerations for biobanking, de-identification, and future research. Participants will leave this session with a robust view of research regulations, innovative ideas to incorporate into protocol design, and a deeper appreciation for patient privacy concerns.
CEU: 1.00 ACRP
Speaker:
Lauren Blizzard, MCR, Emerging Talent Rotational Associate, Merck
Watch a Sneak Peek into the Session Content:
An electronic data capture (EDC) system is software that’s used to electronically collect, manage, store, and export data for the clinical investigations which are critical to support safety and effectiveness claims for drugs, devices, and diagnostic tests. Most EDC systems can be customized to ensure data collection matches the product performance criteria, population characteristics, and statistical analysis plan for a product regulatory submission. This session will describe best practices and pitfalls to avoid when ensuring an EDC system is fit for each unique clinical investigation purpose. Let’s talk about the dos and don'ts and the collaborative sponsor/site/contract research organization approach to EDC validation to make sure we have a clean dataset with the most automated efficiencies and data mapping to scientific endpoints to achieve EDC that's fit for purpose every time.
CEU: 1.00 ACRP
Speaker:
Patricia Smith, Senior Clinical Data Manager, NAMSA
Related Resource:
The new ACRP Guidelines and Regulations Resource Center has the most relevant and up-to-date resources for all professionals whose roles involve conducting and leading clinical research. ACRP will post updates and links to content impacted by the changes to the ICH E6(R3) Good Clinical Practice Guidelines.
In clinical research, the deaf community continues to be a chronically underserved group. Ensuring accessibility for deaf patients can be a challenge without proper guidance. There are many paths to accessibility, including written communication, computer-assisted real-time transcription, use of interpreters, and providers who know American Sign Language, to name a few. This session will focus on strategies to improve accessibility for deaf patients at study sites. Attendees will learn how to choose the right communication method for their patients, interact with interpreters, and incorporate these expenses into the clinical trial budget. This session will challenge attendees to further their understanding of the deaf community and promote advocacy at their sites.
CEU: 1.00 ACRP
Speakers:
Krista Kachnik, BS, Clinical Research Coordinator, The Spine Network
Marcus Stone, PhD, ACRP-CP, Principal, The Spine Network
Watch a Sneak Peek into the Session Content:
Study & Site Management Journey Sponsor
Is it possible to expand clinical trials into networks of community practices if they are given the structure, support, and training needed? The continued transformation of the clinical research enterprise, including a measured improvement in representation of a diverse population in clinical research, depends on a research-ready workforce at community-based clinical research sites that are ready to conduct clinical research responsibly.
With an educational sponsorship from Roche/Genentech, a team of collaborators from Genentech, the Association of Cancer Care Centers (ACCC), and ACRP united to study the impact of clinical research training at ACCC community cancer programs. Join the program leaders as they discuss the results of the impact of providing foundational and therapeutic area-specific clinical research training (oncology) at select ACCC community cancer programs to create a blueprint for training research-naïve oncology staff in the community setting. Included in the discussion are the results of a participant survey that report that learners believed the program improved their knowledge and confidence.
This session does not provide ACRP Contact Hours
Speakers:
Ruma Bhagat, MD, MPH, Senior Director, Health Equity & Population Science (HE&PS), Product Development, Genentech, Inc.
Kimberly Demirhan, MBA, BSN, RN, Assistant Director, Education Programs, ACCC
Mona Gilliam MSN, APRN-BC, CNS, Director Medical Strategy: Congress, Alliances, Societies, Genentech
Kemi Oladipupo, Touro Cancer Center
Marian Valia, Head of Learning & Development, ACRP
Related Content:
Building Research Capacity and Advancing Equity in Community Oncology Clinical Trials: A Pilot Training Program [Poster Presentation]
Readying Community Cancer Centers for Getting into Clinical Research [Blog]
Study & Site Management Journey Sponsor
Applying for institutional review board (IRB) review can be a daunting process when you don't understand how these boards function or why their decisions are so important. What application do I use for my study? What's the big deal about consent forms? How long will review take? Why do similar-sounding studies earn different decisions? The IRB review process can seem quite opaque initially; however, most IRBs use similar processes and a lot happens behind the scenes to bring order out of potential chaos. In this session, you will learn the base rules and regulations IRBs follow when reviewing applications, the possible outcomes following review, and the general flow most IRBs use when reviewing applications.
CEU: 1.00 ACRP
Speaker:
Ben Mooso, MS, CCRP, Director, Office of IRB Administration, UC San Diego
Watch a Sneak Peek into the Session Content:
This session focuses on developing essential skills for effective study and site management. Participants will gain practical knowledge in key areas, including protocol implementation, regulatory compliance, and patient recruitment. The goal is to enhance coordinators' competency through hands-on training and real-world scenarios. Key topics include optimizing site workflows, managing study timelines, and ensuring data integrity. Attendees will leave with actionable strategies for improving site performance and study outcomes, making them invaluable assets to their research teams.
CEU: 1.00 ACRP
Speaker:
Tia Warrick, DHSc, MPH, CCRA, ACRP-PM, Chief Executive Officer, Lesous Consulting LLC
Watch a Sneak Peek into the Session Content:
After an inspiring keynote, don't miss the chance to meet resilience expert Allison Massari. Join us for a Meet & Greet in Celestine A-C immediately after the session. Bring your questions!
Signature Series Keynote Session
Artist, resilience expert, burn survivor, entrepreneur, and inspirational storyteller, Allison Massari knows first-hand the healing power of compassion. In this inspiring session, hear how you can be the remedy with simple acts of kindness that take seconds. Leave with actionable insights and ways to incorporate compassionate care into your clinical research practice.
Note: This session WILL NOT be recorded. If you wish to earn contact hours for this session, you must view it live and complete the evaluation within seven days of the session date.
Speaker:
Allison Massari, Interdisciplinary Artist, Executive Coach, Entrepreneur
Related Blog Content:
Related Event:
Explore innovative ideas, research findings, and best practices in clinical research through our engaging poster presentations, displayed in the Expo Hall during open hours. Educational posters are visual summaries designed to present key information in a clear, concise, and compelling way. They allow researchers and professionals to share their work, spark discussions, and inspire new approaches to clinical research challenges.
Authors will be available for in-person Q&A at 1:30 PM on Friday and Saturday. Winners will be announced during the Saturday Networking Reception. We encourage attendees to stop by, view the posters, and engage with the presenters to deepen their understanding of the projects and connect with peers.
Posters:
Biospecimen Collection: The Cornerstone of Clinical Trials
Authors: Kay Murphy, Halley Losekamp
Building Research Capacity and Advancing Equity in Community Oncology Clinical Trials: A Pilot Training Program
Authors: Kimberly Demirhan, Sumanta Pal, Latha Shivakumar, Molly Kisiel, Elana Plotkin
Ghosting? More than a Dating Trend
Author: Leah Orozco
How to Be Your Own Internal Study Monitor
Author: Ann-Marie Jacobson
It’s Not you, It’s me. Where do we go now?
Author: Estela Staggs
Patient-Centered Consent: Bridging Trust in Clinical Research
Authors: Megan Rodgers, Andrea Gutierrez
Pediatric Site Response to Rapid Implementation of Decentralized Clinical Trials (DCTs)
Author: Abigail Kietzman
Site-Enabled Decentralized Clinical Trial Model for Rare Diseases
Authors: Alpa Khushalani, Amy Chestnut
Understanding the Role of CROs and Sponsors During the Feasibility Process to Increase Enrollment for Racial and Ethnic Minorities in Clinical Trials
Author: Jalen Denson
You can learn about the many facets of clinical research and have fun at the same time in this fast-paced game show format. Watch teams pit their knowledge of clinical research against each other until a winner emerges. Audience members will be encouraged to play along as their colleagues are challenged with questions that vary in complexity and subject. Questions may require teams to recall core principles of ICH Good Clinical Practice, eClinical technology, or the basics of informed consent, as examples.
CEU: 1.00 ACRP
Speakers:
Elisa Cascade, MBA, Chief Product Officer , Advarra
Vanessa Hill, Director, Research Compliance, Advarra Consulting - Institutional Research
Christine Senn, PhD, CCRC, CPI, FACRP, SVP, Site-Sponsor Innovation, Advarra
Study & Site Management Journey Sponsor
techXpo Session Sponsored by Milliman IntelliScript
For too long, clinical trial site operators have had to rely on outmoded, time-consuming processes to pre-screen and enroll participants—only to see a significant number of them screen-fail down the line. Relying on participant questionnaires, interview notes, and fragmented medical records is unacceptable in today’s high-tech, data-driven world.
Join this session to learn about Irix®—a groundbreaking software as a service (SaaS) tool that quickly and easily includes or excludes participants at every stage of your unique clinical trial. We’ll discuss:
The challenges you face in recruiting and evaluating participants and how data-driven tools can overcome these hurdles
The limitations of electronic health records and the need to fill in gaps with additional information to improve screening accuracy
How having instant access to your participants’ health information can improve trial outcomes and patient safety
Real-world examples and case studies demonstrating how you can save time and improve efficiency in the recruitment and enrollment process
Irix demo—see for yourself how it modernizes and streamlines screening
Q&A
Speaker:
Alyssa Vincze, Principal and Director, R&D, Milliman IntelliScript
Failure to understand and implement a comprehensive research billing compliance program can result in monetary penalties, close scrutiny from the U.S. Department of Health and Human Services' Office of Inspector General, and loss of reputation to a research institution. Institutions participating in clinical trials must understand the risks. Additionally, they need the knowledge and skills to accurately perform coverage analysis and manage charges based on that analysis. Finally, institutions need tools for conducting internal audits to ensure all processes are followed correctly. In this master class, participants will learn the “why” of having a comprehensive clinical research billing compliance program and can practice their coverage analysis and auditing skills through hands-on activities.
CEU: 1.00 ACRP
Speaker:
Shanna Ford, MHA, Research Office Senior Associate, Huron Consulting Group
Watch a Sneak Peek into the Session Content:
Related Resource:
The new ACRP Guidelines and Regulations Resource Center has the most relevant and up-to-date resources for all professionals whose roles involve conducting and leading clinical research. ACRP will post updates and links to content impacted by the changes to the ICH E6(R3) Good Clinical Practice Guidelines.
Artificial intelligence (AI) and machine learning (ML) technologies are transforming healthcare delivery. Understanding the regulatory framework for study AI/ML utility, accuracy, efficacy, and reproducibility is key to the research process prior to its use in patient diagnosis and care. This is a cutting-edge topic upon which many new federal guidance documents have focused. It is often misunderstood by sponsors, sites, and investigators that if AI/ML is used for diagnosis, the technology it is FDA regulated. Operationally, the inclusion or exclusion of AI/ML findings into the electronic health record is poorly understood, although it is analogous to the 21 CFR 812 Investigational Device Exemption or 510 K pathway used for new laboratory testing procedures.
CEU: 1.00 ACRP
Speakers:
Betty Donoval, Director, Research & Regulatory Affairs, Cook County Health
Pamela Gonzalez, Manager Research Consultant, Huron LLC
Watch a Sneak Peek into the Session Content:
Related Resource:
The new ACRP Guidelines and Regulations Resource Center has the most relevant and up-to-date resources for all professionals whose roles involve conducting and leading clinical research. ACRP will post updates and links to content impacted by the changes to the ICH E6(R3) Good Clinical Practice Guidelines.
This session aims to introduce a strategic approach to workforce development that is rooted in implementation science to support clinical research quality operations, sustainability, and growth. The methodology will demonstrate the strategic integration of the diverse array of educational resources now widely available in the clinical research sector into a staged approach for impactful workforce upskilling. This spans from individual staff development to organizational governance, extending to inter-organizational learning networks. At its core, the upskilling framework calls for aligning workforce development with organizational goals, ensuring education efforts are not only relevant but strategically positioned for transformative change. This adaptability, synchronized with each organization's unique capabilities and maturity, cultivates a culture of continuous learning, stimulating growth and advancing capabilities. This approach offers a flexible solution for the evolving workforce needs in our diverse clinical research landscape and the dynamic challenges of clinical research programs.
CEU: 1.00 ACRP
Speaker:
Thobe Mthethwa-Pitt, Senior TrialHub Clinical Trials Education Manager, Alfred Health
Watch a Sneak Peek into the Session Content:
Join a seasoned U.S. Food and Drug Administration (FDA) Investigator for an overview of how to "stress test" your electronic source (eSource) documents to ensure that they are compliant with FDA regulations and current guidance. This session offers a brief overview of regulatory requirements governing the creation, maintenance, and storage of electronic data at clinical sites and reviews some examples of shortcomings observed in FDA inspections that resulted in FDA Form 483s (Notice of Inspectional Observations) and even Warning Letters. We will also review different types and sources of eSource documentation, including digital health technology, registries used to source real-world data, and electronic medical records, and review common pitfalls associated with them. After the presentation, there will be a live Q&A opportunity.
CEU: 1.00 ACRP
Speaker:
Barbara Wright, JD, Senior Advisor, Office of Bioresearch Monitoring Inspectorate, Office of Inspections & Investigations, U.S. Food and Drug Administration
This session will provide a high-level overview of the emerging regulatory environment governing clinical research. With a new administration in the White House and 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, this is a session providing value for stakeholders across the entire clinical research enterprise.
CEU: 1.00 ACRP
Speaker:
David Vulcano, LCSW, MBA, CIP, RAC, FACRP, VP Clinical Research Compliance & Integrity, HCA Healthcare
Related Resource:
The new ACRP Guidelines and Regulations Resource Center has the most relevant and up-to-date resources for all professionals whose roles involve conducting and leading clinical research. ACRP will post updates and links to content impacted by the changes to the ICH E6(R3) Good Clinical Practice Guidelines.
This session will help attendees learn how project management techniques can streamline the clinical study start-up process. Discover essential skills like time management, risk assessment, and effective communication, and explore practical tools for strengthening them. Through interactive activities, attendees will be able to develop a robust project plan, manage resources efficiently, and mitigate risks. Attendees will also be able to enhance their ability to handle complexities and minimize delays, ensuring timely study initiation. This session is ideal for clinical research professionals aiming to improve start-up efficiency, as it will offer practical takeaways, including templates and checklists, to apply immediately to their work.
CEU: 1.00 ACRP
Speaker:
Megan Lamberti, Vice President of Clinical and Regulatory Affairs, Nilo Medical Consulting Group
Watch a Sneak Peek into the Session Content:
Leadership & Professionalism Journey Sponsor
Advancements in precision oncology have led to the development of life-changing, novel treatment modalities in the clinical trial setting. However, significant disparities persist in who benefits from these treatments. Public health has established core principles to ensure equitable access to care for all. How can the clinical trial landscape benefit by applying these public health principles to ensure equitable access to clinical trials? This session will explore the role of social determinants of health and provide a foundational framework for integrating community-based participatory research (CBPR) into current research projects. Participants will learn strategies to improve patient engagement and outcomes through CBPR. Attendees will leave with practical examples and methods to measure the success of their health equity initiatives in clinical research.
CEU: 1.00 ACRP
Speaker:
Related Blog Content
Watch a Sneak Peek into the Session Content:
Study & Site Management Journey Sponsor
We are experiencing serious shortfalls in the number of clinical research physicians (principal investigators) needed to keep the enterprise healthy, in part due to aging populations and to the aftereffects of restrictions and burnout from pandemic conditions. It is estimated that less than 5% of U.S. physicians are participating in clinical research at any given time. Is there a sustainable path to attracting and retaining new and returning physicians for conducting clinical studies? With approximately 70,000 clinical studies ongoing or planned, and 35% being U.S.-only, the challenge is to create a collective approach addressing the gap ahead. Sponsors, contract research organizations, site networks, and medical associations realized during the worst days of COVID-19 that collective minds create solutions. Engaging/involving more "research naïve" physicians is a key to success for stakeholders everywhere. Understanding what these physicians need is important. This panel will include physicians who are new to the principal investigator role. Why did they add clinical research to their patient-care services? What have they learned? Why have they continued in clinical research? Are their communities showing greater interest? What are their enrolled patients sharing with them about their experiences as participants?
CEU: 1.00 ACRP
Speakers:
Edwin Burkett, MD, Chief Medical Officer, Alliance Medical Ministry
Amir Herman, DO, Medical Director, East Northport Medical Care
Nancy Sacco, PhD, VP Head of Clinical and Site Development Operations, SiteBridge Research Inc
Related Resource:
The new ACRP Guidelines and Regulations Resource Center has the most relevant and up-to-date resources for all professionals whose roles involve conducting and leading clinical research. ACRP will post updates and links to content impacted by the changes to the ICH E6(R3) Good Clinical Practice Guidelines.
Study & Site Management Journey Sponsor
Your patient recruitment engine is the machine that fuels your site's success. Regardless of your wins or losses, every site wants to improve and add efficiency to its recruiting process. Chances are, a lot of what you're already doing is right, but there seems to be something new every day that clinicians can't resist seeking--the next "silver bullet" for marketing and recruiting. It's easy to feel you're behind in the space. It's easy to think you're over- or under-invested. It's easy to ponder that others are finding patients you're not. This session is designed to ease those fears. Find out about the things you think you might be missing. We'll discuss the media options sites are using, spend some time on the new things you keep hearing about, and give you the tactics to evaluate your recruiting operation. Then you can decide where best to allocate resources and grow.
CEU: 1.00 ACRP
Speaker:
Mark Metzner, Senior Manager, Patient Recruiting & Feasibility, CTI Clinical Trial Services, Inc.
The assurance of study subjects' privacy and confidentiality is fundamental to the enrollment of participants in clinical research. At the same time, the number of datapoints collected and commodified by the commercial world on each individual has increased exponentially. The potential overlap or convergence of these datastreams, whether intentional or inadvertent, threatens the promise of privacy. This session will explore the range and means of data collected in the pursuit of human research and the limits of protections possible in today's digital world.
CEU: 1.00 ACRP
Speaker:
Robert Romanchuk, CIP, Chairperson, Univo IRB
Watch a Sneak Peek into the Session Content:
Related Resource:
The new ACRP Guidelines and Regulations Resource Center has the most relevant and up-to-date resources for all professionals whose roles involve conducting and leading clinical research. ACRP will post updates and links to content impacted by the changes to the ICH E6(R3) Good Clinical Practice Guidelines.
techXpo Session Sponsored by RealTime eClinical Solutions
Managing clinical trials can feel overwhelming when systems are disconnected and data are scattered. In this techXpo, we’ll explore how a site operations management system (SOMS) transforms chaos into streamlined efficiency. Learn how an integrated platform strengthens compliance, improves workflow automation, and boosts overall site performance—empowering research teams to focus on what truly matters: advancing clinical trials.
Speakers:
Rick Greenfield, BBA-IS, Founder & Chief Strategy Officer, RealTime eClinical Solutions
Nathan Levens, Vice President of Product Strategy, Head of Quality Management, RealTime eClinical Solutions
Signature Series Session
Join ACRP’s Executive Director and board members in a town hall setting for an open mic event that will geaux beyond a typical conference kick-off! We'll explore the importance of community, connection, and maintaining confidence in uncertain times and invite you to bring your experience and best ideas to support your colleagues during demanding times. Let’s convene to talk strategies for coping and use the power of networking to support our community of clinical research professionals.
CEU: 1.00 ACRP
Speakers:
Christina Brennan, MD, MBA, CCRC, FACRP, Senior Vice President, Clinical Research, Northwell Health
Catherine Gregor, MBA, CCRC, Chief Clinical Trial Officer, Florence Healthcare
R'Kes Starling, RPh, MBA, Chief Executive Officer/President, Reveles Clinical Services
Susan P. Landis, Executive Director, Association of Clinical Research Professionals (Moderator)
Join us in the Expo Hall for networking with exhibitors and fellow clinical research professionals! Enjoy meals and connection opportunities throughout the day:
Breakfast: 8:00 – 9:00 AM
Networking & Exhibits: 8:00 AM – 2:00 PM
Lunch: 12:45 – 1:45 PM
Networking Reception: 4:30 – 6:00 PM
Visit the HCA Healthcare Headshot Studio during the times below for a complimentary professional headshot!
8:00 – 10:30 AM
12:00 – 2:00 PM
4:30 – 6:00 PM
Join us for breakfast while connecting with 100+ leading-edge organizations and suppliers helping you get better results in clinical research.
When you arrive in New Orleans, make your way to the registration area to receive your conference badge and essential materials, ensuring you're fully equipped for four days of engaging education sessions and valuable networking experiences.
