Clinical research staffing demands ebb and flow during the protocol and subject management lifecycle. In this session, Jaylene Weigel (Senior Director of Clinical Research Management and Support, Children’s Mercy Hospital) and Emily Traw (Consulting Manager, Huron) will discuss their experience validating the need for a centralized clinical research professionals support model, review essential elements of the model design process, provide an overview of benefits and drawbacks of the model and rationale for use at Children’s Mercy, and lessons learned during implementation. This session is appropriate for all levels of attendees, but particularly those in leadership roles. Attendees will walk away with an understanding of the processes and tools used as this site identified and designed their staffing model.

CEU: 1.00 ACRP

Speakers:

• Emily Traw, Consulting Manager, Huron Consulting Group

• Jaylene Weigel, Senior Director of Clinical Research Support and Management, Clinical Trials Office, Children's Mercy Hospital

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Most federally funded, multisite studies already require oversight by a single institutional review board (sIRB), and soon that likely will be true for U.S. Food and Drug Administration-regulated studies. It’s no secret that sIRB review presents challenges for study teams, especially those managing investigator-initiated studies. This session will help you understand your responsibilities related to sIRB review and point you to resources you can take advantage of.

CEU: 1.00 ACRP

Speakers:

• Polly Goodman, Associate Director of Regulatory Affairs Operations, SMART IRB, Harvard Catalyst | The Harvard Clinical and Translational Science Center

• Michael Linke, PhD, Adjunct Professor/Director of Education, University of Cincinnati/SMART IRB

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Clinical research regulations, guidances, and advisories that come in an unending stream from the U.S. Food and Drug Administration are a fact of life that no one in the professional can afford to ignore. This session provides a high-level overview of recent and emerging regulatory issues in the conduct of clinical trials and other kinds of research in the United States.

CEU: 1.00 ACRP

Speaker:

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

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If you were inspired by the Signature Series presentation “We’re On This Journey Together,” want to hear more about the panelists’ initiatives, and are keen to ask questions of them, this is the session for you. If you are also interested in sharing what you, your team, and your organization have learned from your own clinical research outreach and improvement initiatives in a lively setting, here’s your chance to spread the word. This follow-up session to Monday morning’s gathering continues the conversation started there, and allows audience members the opportunity to ask questions and share the best practices they have cultivated for promoting excellence in and awareness of clinical trials in their workplaces and communities.

Speakers:

• Rick Fisher, Senior Vice President, Operations, Velocity Clinical Research

• Erin Stackowitz, US Innovation Lead, Clinical Study Unit, Sanofi

• Nancy Sacco, PhD, VP Head of Clinical and Site Development Operations, SiteBridge Research Inc (Moderator)

This panel discussion reviews the ethical, regulatory, and operational challenges of conducting Exemption from Informed Consent (EFIC) trials in cases involving life-saving, emergency treatments when obtaining consent is impossible.

CEU: 1.00 ACRP

Speakers:

• Kammy Jacobsen, PECARN Program Director, University of Utah, Data Coordinating Center

• Ann Johnson, MPH, IRB & HRPP Director, University of Utah, Institutional Review Board

• John VanBuren, PhD, Associate Professor, University of Utah

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What if we could bring clinical trial opportunities right to where potential participants get their annual physical, their flu vaccine, and the majority of their care? Hear from an investigator and a leader from an integrated research organization as they discuss the challenges and how they overcame them to build a successful research partnership in a community-based primary care practice.

CEU: 1.00 ACRP

Speakers:

• Charlotte Grayson-Mathis, MD, Internal Medicine Specialist, First Georgia Physicians Group (Privia Health)

• Ashley Moultrie, CCRP, Director, DEI & Community Engagement, Javara