SOCRA 2024 Annual Conference Program Book - Flipbook - Page 43
SATURDAY, SEPTEMBER 28, 2024
BREAKOUT SESSIONS
TRACK 6: QUALITY MANAGEMENT
PAVILION 10
PAVILION 9
Moderator: Jane De Jesus, BSc, BA, CCRA, CCRP
Moderator: Rachel Kingsford, MS, CCRP
Sat., Sept 28 3:45 to 4:30
Track: Quality Management
Quality Assurance and associated Challenges at the
Resource Limited, Rural Research Site
Ms. Wandile will consider the issues related to managing
clinical trials at a rural site. 629
Presenter: Pranali Wandile, MS, CCRP, Clinical Research
Manager, Low Country Pain Center LLC
Sat., Sept 28 4:35 to 5:20
Track: Quality Management
Creating A Clinical Research Quality Assurance
Program From Scratch
Each medical test site must establish and follow policies
and procedures for a comprehensive quality assurance
(QA) program. Where to start? What is needed? 631
Presenter: Karima Yataghene, MD, Senior Director, Clinical
Research Quality Assurance, Memorial Sloan Kettering
Cancer Center
TRACK 7: SITE MANAGEMENT
TRACK 7: SITE MANAGEMENT
PAVILION 9
Moderator: Jane De Jesus, BSc, BA, CCRA, CCRP
Sat., Sept 28 8:30 to 9:15
Track: Site Management
Strategies for Development, Implementation, and
Maintenance of SOPs to Improve Research Operations
Ms. Gauthier and Ms. Salazar will highlight how to
maximize the benefits that SOPs bring to both sites and
sponsors/CROs while also including real-world examples
of how SOPs improve not only research compliance but
research operations as a whole. 717
Presenters: Phoebe Gauthier, MA, MPH, Research Scientist,
Geisel School of Medicine at Dartmouth College
Dagmar Salazar, MS, Manager of Clinical Study
Management, The Emmes Company, LLC
Sat., Sept 28 9:20 to 10:05
Track: Site Management
Site First Technology - What is it and How to Deploy it
Successfully
Mr. Wright will discuss what it really means to be a site
first technology. Why a partnership and good
communication between all stakeholders is important.
719
Presenter: Keith Wright, MBA, CCRP, Director, Industry
Strategy and KOL, Advarra
Sat., Sept 28 10:50 to 11:35 Track: Site Management
The Regulatory Inspection Process: How to Always be
Audit Ready
Ms. Noitsis will discuss how to be prepared for a GCP
inspection or audit. Best practices to be implemented
including behavior dos and don'ts will be highlighted.
721
Presenter: Flora Noitsis, Hons. BSc, Senior Associate, Quality
& Compliance, BioAcuity Consulting, Inc.
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Sat., Sept 28 11:40 to 12:25
Track: Site Management
Tech Roots at Sites - How a 2023 Change, Changes
Everything
Ms. Gregor will discuss why the next wave of tech
innovations are owned and controlled by sites, and how
to select sites and implement and negotiate
reimbursement from sponsors in order to thrive in this
new world. 723
Presenter: Catherine Gregor, MBA, CCRP, CCRC, Chief
Clinical Trial Officer, Florence Healthcare
Moderator: Amanda Galster, MPH, CCRP
Sat., Sept 28 1:40 to 2:25
Track: Site Management
What's Data Got to Do with It? Data Essentials for the
Clinical Research Professional
Ms. Helm will explore the various stages included in a
DMP, from study set-up to data collection through data
lock, and consider the regulations and guidelines related
to good data management practices. Clinical Research
Professionals (CRPs) are pivotal to ensuring that study
data supports the overall conduct of ethical and
scientifically valid clinical research. 725
Presenter: Shirley Helm, MS, CCRP, Senior Adminstrator for
Network Capacity & Workforce Strategies, Virginia
Commonwealth University
Sat., Sept 28 2:30 to 3:15
Track: Site Management
Beyond DCTs: The Future of Modernization in Clinical
Trials
The future of clinical trials may be dependent upon more
flexible and adaptive technologies that connect sites,
sponsors, CROs, and patients in a more meaningful way.
Ms. Gregor will focus on what the future will look like
with a more integrated technology landscape and the
tangible benefits for patients and sites. 727
Presenter: Catherine Gregor, MBA, CCRP, CCRC, Chief
Clinical Trial Officer, Florence Healthcare
Sat., Sept 28 3:45 to 4:30 Track: Site Management
Break the Blind Escape Room Adventure
Ms. Flynn will discuss partial and full un-blinding in
clinical trials. The talk will be followed by a hands on
"escape room" activity where participants attempt to
unblind a trial with only the clues provided. 729
Presenter: Gayle Flynn, BA, ALM, Senior Director, Cognizant
