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

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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

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Research team retention and engagement heavily impacts enrollment and program performance. Join Michelle Rowe from HCA Healthcare Research Institute, as she leads a discussion on talent retention, onboarding, and colleague development. During the panel discussion attendees will hear from HCA Healthcare leaders from Site Operations, Quality & Compliance, Strategic Projects, and Human Resources on the important challenges facing programs today and practical and effective pathways forward. Leave the discussion with knowledge on approaches to onboarding across over 43 sites of care with a core belief that HCA Healthcare's greatest strength is its talent. Discover practical strategies to standardize talent retention by making actionable ownership of colleague development an intrinsic part of the culture of your program.

This session does not provide ACRP Contact Hours.

Speakers:

• Andrea Berkovsky, Director of HR, HCA Healthcare Research Institute

• Lauren Horton, PhD, Director of Research, North Texas Division, HCA Healthcare Research Institute

• Sybil Hyatt, MBA, RN, AVP Site Operations, HCA Healthcare Research Institute

• Kristen Oakes, Manager of Strategic Projects and Programs, HCA Healthcare Research Institute

• Michelle Rowe, RN, VP, Research Institute, HCA Healthcare Research Institute

• Robbin Seago, AVP Research Ethics & Compliance, HCA Healthcare Research Institute

This session is sponsored by

One of the predominate challenges we face in our field is not having enough "hands on deck" to tackle all the work in front of us. This principal issue is accompanied by a litany of subsequent challenges that impact managers, coordinators, sponsors, stakeholders, and most importantly, study patients. We will discuss how to keep a team of research professionals seaworthy across entire studies by diminishing the strain on its members through provision of "floating coordinators" giving temporary coverage for projects and departments on an as-needed basis. We will break the ice on this topic, which we believe will become increasingly relevant, and we'll share our top tips for instituting and managing such programs wherever they are needed in the research enterprise.

CEU: 1.00 ACRP

Speakers:

• Michelle Bright, MA, CCRP, Director of Clinical Research Operations, Center for Clinical Research Management, Ohio State University College of Medicine

• Diana Burke, MA, CCRC, Lead Clinical Research Coordinator, Center for Clinical Research Management, Ohio State University College of Medicine

• Patrick Rowan, MS, CCRP, Senior Clinical Research Coordinator, Center for Clinical Research Management, Ohio State University College of Medicine

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Join us for an engaging, fun-filled session where staff from a large healthcare and research organization will share practical strategies for creating a workshop course series that elevates informed consent training from adequate to superior heights. Identify tactics to address gaps in your informed consent education and to navigate unique informed consent scenarios. Learn how to utilize gameplay applications and simulation activities, and how to share the knowledge of experienced clinical research staff to improve the practices of your novice clinical research workforce. Discover how to enhance your clinical research operations through empowerment of your teams to offer research opportunities to diverse clinical trial participant populations in non-ideal conditions--all while keeping your training exciting and interesting.

CEU: 1.00 ACRP

Speaker:

• Cathe Hanson, Education Coordinator - Research, Mayo Clinic

• Pam Draayer, CCRP, Education Coordinator - Research, Mayo Clinic

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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.

We will examine the evolution of the clinical research coordinator (CRC) role, focusing on the impacts of traditional job descriptions and requirements assigned to the role. We will also look at how the mindset resulting in a “gatekeeping” approach for hiring impacts potential new CRCs' interest in and recruitment/retention for the role. Comparing the traditional requirements of 2-3+ years experience in the field for CRC roles puts many qualified candidates out of the running when they have transferable skills. This panel will provide a collaborative platform for discussions and dialogue regarding past, present, and future practices, and responsibilities of the next generation of CRCs. A primary focus for this session will be examining the changing research landscape and encouraging reflection on the impacts of recent trends on sites/studies. Through panel members sharing experiences and attendees engaging throughout the session, participants will gain insights into the value of more inclusive hiring practices and strategies to promote diversity in the field.

CEU: 1.00 ACRP

Speakers:

• Micki Le, Director or CRCs and PMs, SiteBridge Research

• Lauren Stockwell, Content & Engagement Manager, Society for Clinical Research Sites

Related Blog Content:

• Opening the Gates to New Study Coordinator Talent and Workforce Mindsets

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Clinical research represents a robust profession with many enticing factors: advancement opportunities, diverse skill application, good pay, and the potential to play a significant role in improving healthcare. However, development of a sustainable, diverse, and talented workforce has several known barriers. Among these are limited awareness of clinical research career and training opportunities compounded by a persistent catch-22 requiring prior work experience for entry-level positions. Here we explore a few of the innovative new models that are tackling these critical issues. From clinical research competency training in high schools, equity-focused internships, employer-based apprenticeship programs, and city-site partnerships to support economic development through CRP training and placement, employers and educators are using creativity and collaboration to reduce roadblocks and forge new pathways into the clinical research workforce.

CEU: 1.00 ACRP

Speakers:

• Stephanie Freel, PhD, PMP, Director, Clinical Research Operations, Education & Outreach, Duke University

• Olga Kishchenko, CCRP, Education Program Manager, UC Davis Health

• Leshon Matthews, AAS Clinical Trial Research Associate, Clinical Research Specialist Senior, Duke University

• Sharleen Traynor, PhD, MPH, Director, Clinical Trials Research Associate Program, Durham Technical Community College

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