Site Management
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2023 Agenda
Saturday, September 30th at 8:30 to 9:15 Track: Site Management
How to Build a Robust Student Research Training Program
Ms. Jones will initiate a discussion that goes step by step into how to build a volunteer student research training program from recruitment, curriculum, and support to research projects. We will discuss ow to set up mentorship and support for a mutually beneficial experience as a direct feed into positions at your institution and to support studies with limited financial resources. 517
Presenter: Laura Jones, BA, CCRP, IRB Principal Analyst, UC San Diego
Saturday, September 30th at 9:20 to 10:05 Track: Site Management
What is it really like switching from paper to eRegulatory.
How does the transformation work? How long does it take? What can you do to make it most effective as a tool? What are the positives and pitfalls? In the end, is it really worth the cost and effort? 519
Presenter: Mark Sulik, PharmD, CCRP, Director of Clinical Research, Rocky Mountain Diabetes Center
Saturday, September 30th at 10:50 to 11:35 Track: Site Management
Leading with Purpose - How to Build and Maintain a Resilient Clinical Research Team
Ms. Wentzel has been leading a multi-dimensional clinical research team for over 25 years. She will share lessons learned as well as strategies and tactics for interviewing, team-cohesiveness and, most importantly, retention. 521
Presenter: Grace Wentzel, BA, CCRP, CHRC, Executive Director, Site Operations, Javara
Saturday, September 30th at 11:40 to 12:25 Track: Site Management
Good Clinical Practice in an Electronic-Based Records System
Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, recording, and reporting trials that involve the participation of human subjects. GCP principles help assure the safety, integrity, and quality of clinical trials by addressing elements related to the design, conduct, and reporting of clinical trials.
Electronic-Based records systems are being increasingly used in the conduct of clinical research. They enable the capability to streamline data transfer, remote enrollment capabilities, greater transparency of the trial conduct, improved research documentation, clearer audit trails and to solve the challenges of physical document storage constraints at trial sites.
From a monitoring perspective, Ms. Wright will discuss the basics of GCP in an electronic-based records system, highlight the importance of a culture of total quality, how to identify challenges, as well as offer solutions for good recordkeeping practices. Examples will be provided. 523
Presenter: Alicia Wright, MS, CCRP, Clinical Research Associate III, Vanderbilt University Medical Center
Saturday, September 30th at 4:35 to 5:20 Track: Site Management
Implementing a Workforce Development Program: Training and Retaining Entry Level Talent to Address the Critical Shortage of Clinical Research Personnel
The supply of clinical research personnel is not keeping up with the growing demand, across the industry, but especially at academic health centers. Ms. O’Malley will briefly discuss the factors and barriers that have contributed to the critical shortage of experienced research personnel and describe an innovative model to address the need. The presentation will describe the difficult but surmountable journey to create a sustainable program to train and retain entry level clinical research personnel and create a diverse workforce. 531
Presenter: Kathleen O'Malley, BSN, RN, CCRP, Director of Education and Training, Jefferson Clinical Research Institute, Thomas Jefferson University