Research - Laboratory/Non-Laboratory, Staff/Administrative
Position Type : Full Time
The Clinical Trials Regulatory Coordinator primary role is the management and oversight of regulatory affairs and compliance for the Clinical Trials Unit in the Division of Gyn Oncology. The essential functions of the position include but are not limited to:
Provide regulatory support for government and industry sponsored, as well as investigator initiated clinical trials in Gyn Oncology. Oversee initial IRB, CTSRMC and biosafety regulatory submissions and protocol amendments. Work with the Director of Clinical Trial Operations in GYN Oncology to implement appropriate policies and best practices for regulatory management. Develop and maintain regulatory files for Gyn Oncology; work with study monitors and auditors to satisfy regulatory requirements.
Internal Number: 45552
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