This session will provide a high-level overview of the emerging regulatory environment governing clinical research. There are many trends to keep track of as actions by the current administration in the White House affect available funding, workforce readiness, and research priorities in governmental, academic, industry, and private practice settings.

Further, recent and forthcoming updates to various U.S. Food and Drug Administration guidance, International Council for Harmonization guidelines, and ethical, safety, and efficacy concerns in the design and conduct of drug and device clinical trials will make this a valuable session for all stakeholders across the entire clinical research enterprise.

CEU: 1.00 ACRP

Speaker:

• David Vulcano, LCSW, MBA, CIP, RAC, FACRP, Vice President, Clinical Research Compliance & Integrity, HCA Healthcare

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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

Related Blog Content:

• AI in Oncology Clinical Research: Accelerating Patient Matching for Trials

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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

Speakers:

• Melissa Gottke, BA, CIP, IRB Chairperson, Advarra

• Amanda Higley, MS, PhD, CIP, IRB Chair Director, Advarra IRB

• Robert Romanchuk, CIP, BSHS, Chairperson, Regulatory Director, Univo IRB

Related Blog Content:

• Shining a Light on IRB Decisions: Mock IRB Meeting Reveals Processes

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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

Speakers:

• Tamika Harris, Clinical Operations Manager - Regulatory, Merck

• Jessica Propps, ACRP-CP, Clinical Operations Manager - Regulatory, Merck

Related Blog Content:

• Developing the Clinical Research Career Transition Roadmap

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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, FACRP, Director, Clinical Trials Operations, University of New Mexico Hospital

Related Blog Content:

• Project Management Benefits Span Strategic Initiatives and Daily Tasks

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.

Celebrate ACRP’s 50th Anniversary with connection, community, and a little bit of nostalgia! Join fellow attendees for a special party where you’ll gather with the people who’ve shaped our journey—and those who will lead its future. Whether you're a seasoned pro or just getting started, this is your moment to connect across generations, share stories, and celebrate your impact. Let’s envision the possibilities for what’s to come in the next fifty years of clinical research—together!

More details to come in 2026!