Central Virginia

Central Virginia SOCRA Chapter Meeting

“Ensuring Regulatory Compliance as a Study Team Member” 

Date: Wednesday, August 24, 2022

Time: 11:00am – 12:00 pm

Location: Zoom, registration required

Speaker: Bret Brooks
Bret is a Certified Clinical Research Coordinator in the VCU School of Nursing Office of Research, Scholarship, and Innovation. Bret started in the VCU SON in February of 2021 after working in the Department of Internal Medicine at VCU where he was a Clinical Research Associate and Regulatory Specialist working on various industry-funded clinical trials. He currently coordinates 2 studies in the SON: the RECOVER-LEGACI Long COVID study and the PRenatal opioids, Infant Sleep, and the gut Microbiome (PRISM) study. Bret’s biggest motivation and ultimate research career goal is to increase access to research for the most underserved and historically-excluded populations and help to translate that into healthcare for our most vulnerable communities.

Learning Objectives: At the conclusion of this presentation, the learner will be able to:

  • Discuss the transformation of abstract regulations and guidelines into specific SOPs and best practices for a study or research program.
  • Learn strategies to maintain study data and essential/source documents in an audit-ready state.
  • Briefly discuss the relationship between and importance of regulations and ethical standards, and identify some of the impacts on research participants, with a focus on the most vulnerable communities and populations.

JTF Competencies
Domain #2: Ethical & Participant / Safety Considerations
Domain #4: Clinical Study Operations
Domain #5: Study & Site Management

CE: 1.0 CE credit hour for SOCRA CCRP Renewal. Only SOCRA members receive Certificates of Attendance. The Society of Clinical Research Associates (SOCRA - www.SOCRA.org) accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area. 

Please share this announcement with your colleagues.
SOCRA members and non-members welcomed!

Central Virginia SOCRA Chapter Chair
Shirley Helm, MS, CCRP                                                                                                                                                
contact cctrsocra@vcu.edu                                                   

Chapter Chairperson:

Shirley L.T. Helm, MS, CCRP
Phone: 804-628-2942

Patricia A. Feldt, CCRP
Phone: 804-628-1902