Director, Regulatory & Administrative Affairs - Institute for Transformative Clinical Trials
About The Position
The Director of Regulatory & Administrative Affairs for the Mount Sinai Institute for Transformative Clinical Trials provides strategic leadership and operational oversight for regulatory, safety, and administrative activities supporting a portfolio of sponsor-led, investigator-initiated, federally funded, and industry-sponsored clinical research studies. Serving within an Academic CRO and Data and Clinical Coordinating Center environment, this position is responsible for regulatory oversight of domestic and international multicenter clinical trials conducted across participating research institutions. The Director provides leadership for regulatory affairs and safety operations activities across the study lifecycle, and ongoing support of participating sites within multicenter clinical research networks.
Requirements
- Demonstrated experience with FDA and Health Canada submissions.
- Experience with Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications.
- Experience with Institutional Review Board (IRB) submissions (sIRB and local IRB).
- Experience with regulatory oversight of multi-center human subjects research.
Responsibilities
- Provides strategic leadership and operational oversight for regulatory, safety, and administrative activities supporting a portfolio of sponsor-led, investigator-initiated, federally funded, and industry-sponsored clinical research studies.
- Responsible for regulatory oversight of domestic and international multicenter clinical trials conducted across participating research institutions.
- Provides leadership for regulatory affairs and safety operations activities across the study lifecycle.
- Provides ongoing support of participating sites within multicenter clinical research networks.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
No Education Listed
