SOCRA 2023 Annual Conference Brochure - Flipbook - Page 20
SATURDAY, SEPTEMBER 30, 2023
BREAKOUT SESSIONS
TRACK 5: STUDY START UP
Time: 2:30 to 3:15
Track Study Start-Up
Tips and Tricks: Improving Study Success Through
Comprehensive Internal Feasibility Considerations
Feasibility considerations are fundamental for both
sponsors and sites conducting clinical research. Yet,
sometimes study protocol specific areas are not
explored sufficiently on the front end leading to delayed
study start-up, poor enrollment, and protocol
noncompliance. This session will cover how to conduct
thorough and consistent internal feasibility reviews
including special considerations such as cybersecurity.
527
Presenters: Cynthia Dunn, MSN, CCRP, RN, CCRA,
Clinical Research Consultant, Crescent City Research
Consulting LLC
Wendy Portier, MSN, RN, CHRC, CHC, Consultant, Portier
& Associates, LLC
TRACK 5: SITE MANAGEMENT
Time:3:45 to 4:30
Track: Study Start-Up
Building Coordinator and Clinical Investigator Work
Relationships
Learning the role of the coordinator is difficult. Learning
effective communication strategies in working with your
site clinical investigators and research team is not
typically offered in training. This session provides
guidance and useful strategies for effective
communication as well as the importance of
documenting that communication. 529
Presenters: Margret Kamel, PhD, CCRC, Associate
Director of Research Projects, Emory University
Teri Crumb, MSN, RN, CCRC, Project Manager, Pediatric
Nephrology Research Consortium
Time: 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 Univ
19
TRACK 6: TRAINING
Time: 8:30 to 9:15
Track: Training
Get Out of a Mess: Managing and Preventing Difficult
Situations
It may happen that you inherit an assignment (project or
trial site, etc.) which is handed over to you not in the
best shape. To run a business up to high standards you
must fix a backlog of the existing problems to make it
work as required. It might be overwhelming. “How do I
start? What should I do? Is there any guidance?” - these
might be the questions running through your head. But
don't panic! In this talk, we’ll share our experience in
handling complex situations, explaining priorities and
chain of actions to achieve a desired outcome. Practical
examples of difficult management situations and
solutions will be provided. 617
Presenters: Fiona Kearney, MSc, Senior Director, Study
Finance Lead, PPD, part of ThermoFisher Scientific
Anatoly Gorkun, MD, PhD, Chartered MCIPD, Associate
Director Global Project Management, PPD, part of
ThermoFisher Scientific
Time: 9:20 to 10:05
Track: Training
Creating & Implementing a Study Management Training
Program: You don’t know what you don’t know
Setting your study up for success starts with training.
Training study staff has been a burden for institutions,
large or small, and finding the best mechanisms for
training can be overwhelming. This session will review the
development of a clinical research onboarding program
that encompasses everything from negotiating study
budgets and managing the study to ensuring compliance.
The program is applicable to the individual or a group
and includes elements for all learning styles. This will be
presented in a way that will be generalizable to other
institutions. 619
Presenters: Megan Robb, BA, Senior Training &
Compliance Coordinator, Nationwide Children's Hospital
Christine Baker, BA, CCRP, Team Leader-Regulatory
Affairs, Nationwide Children's Hospital