Closing Plenary

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2023 Agenda

Sunday, October 1st at 8:40 to 9:25                                                                                          Track: Closing Plenary

Clinical Research – A New Call to Action

Recent public health concerns, court rulings, and international trade and commerce discussions have made clinical research more visible than ever before. As a result, the clinical trial enterprise is rethinking everything from trial design to technology to enrollment to finance. However, has the reimagining of the clinical trial enterprise resulted in improved public health? This talk will look at the future of clinical research and the concrete steps that must be taken in order for clinical research to have the powerful impact it was always intended to have. 901
Presenter: Quincy Byrdsong, EdD, CCRP, CIP, Vice President, Research Operations, Ballad Health

Sunday, October 1st at 9:25 to 10:10                                                                                               Track: Closing Plenary

Generations in the Workplace: Now and Looking Forward

The current American workplace includes five generations. i.e., Traditionalists, Boomers, Gen Xers, Gen Y and Gen Z with a sixth to join in the foreseeable future, i.e., Gen Alpha. This presentation will include an update on the interactions of the current generations, including diverse perspectives on each's impact on the workplace and views on each other, as well a look ahead to the introduction to the next generation to arrive. 903
Presenter: Barbara van der Schalie, MS, Senior Clinical Training Manager, Leidos Biomedical Research Inc

Sunday, October 1st at 10:30 to 11:30                                                                           Track: Closing Plenary

Leading a Successful Research Program: Perspectives on Success and Innovation

"Leading a successful research program is the same as running a business. Both depend on innovation, collaboration, and reputation for success, yet few young investigators are prepared to lead research teams as they launch independent careers."1 Yet, often hidden from manuscript publications, university press releases, and media interviews are experienced research professionals. Hard-working clinical research professionals rise to leadership roles every day to ensure successful and high-quality patient engagement, site management, and data collection. In this talk, three seasoned industry professionals will describe strategies for convening effective research teams, building collaborative relationships with research sites, and embracing passion to drive a legacy for the clinical research profession.

1. Una E. Makris, MD, MSc1 Leadership Lessons: Building and Leading a High-Performing Clinical Research Team. J Am Geriatr Soc. 2018 July ; 66(7): 1258–1261. 904
Presenter: Bradley Hightower, BA, CCRC, CEO, Hightower Clinical
Presenter: Danielle Mitchell, BS, Owner and CEO, Black Women in Clinical Research
Presenter: Laura Holtz, MS, PMP, CCRP, Clinical Research Associate, Yale School of Medicine - YCCI

Sunday, October 1st at 11:30 to 12:00                                                                                      Track: Closing Plenary

Incorporating Lessons Learned from the Pandemic in your Everyday Informed Consenting Process

While guidance documents issued by the FDA and many IRBs during the pandemic were intended to remain in effect only for the duration of the COVID-19 public health emergency, the flexibility and technological advances adopted by many sponsors and research sites could enhance and facilitate the consenting process for participants and staff beyond the pandemic. We will reflect on our experiences during the past three years as we were conducting research studies throughout the pandemic. We will discuss how to incorporate lessons and techniques learned during that time that meet regulatory requirements and that improve consenting during adverse conditions. 906
Presenter: Lisa Harewood, CCRP, Clinical Trials Regulatory Specialist II, Hope Clinic of Emory Vaccine Center
Presenter: Ellie Butler, MS, JM, CCRP, Clinical Trials Regulatory Specialist, Emory University