Sponsor Responsibilities
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This presentation will provide an overview of the sponsor responsibilities for conducting clinical research. The presentation will address sponsor responsibilities for regulatory submissions, site selection, documentation, and monitoring. Safety and regulatory reporting will also be discussed. As clinical trials expand throughout the globe, it is important to understand the regulatory and ethical responsibilities of the Sponsor.
LEARNING OBJECTIVES:
Describe sponsor responsibilities for conducting clinical research
Discuss responsibilities for regulatory submissions, site selection, documentation and monitoring
Discuss safety and regulatory reporting
Amy Jo Jenkins, MS, CCRP
Associate Director of Administration / Instructor
Winthrop P. Rockefeller Cancer Institute, University of Arkansas for Medical Sciences
Amy Jo Jenkins has 20+ years of experience working in clinical research and currently serves as the Executive Director of the Translational Research Institute at the University of Arkansas for Medical Sciences, where she also teaches courses in the Regulatory Science Program. She earned her Masters of Science degree in Clinical Research Organization and Management from Drexel University and Bachelors of Science degree in Molecular Biology from Grove City College. She has been a Certified Clinical Research Professional since 2010 and has served on the SOCRA Board of Directors since 2016.