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Posted Job Title
Clinical Research Regulatory Specialist C
Job Profile Title
Clinical Research Regulatory Specialist C
Job Description Summary
This position will be a resource for best practices of regulatory management and oversight with NIH and Industry-sponsored clinical trials in the Neuroradiology Clinical Research Division. The position involves leading regulatory operations for clinical research, independently managing submissions to IRBs, committees, sponsors, CROs, FDA, and regulatory agencies. He/She will oversee regulatory documentation, resolve complex compliance issues, direct study initiation, monitoring, audit, and close-out visits. He/She will serve as a liaison for regulatory oversight with investigational teams, nursing units, sponsors, and CROs. Other responsibilities include the development of regulatory tools and processes, providing expert regulatory and compliance guidance, and training/mentoring junior staff in regulatory practices and study oversight.
Job Description
Job Responsibilities
This position will be a resource for best practices of regulatory management and oversight with NIH and Industry-sponsored clinical trials in the Neuroradiology Clinical Research Division. The position involves leading regulatory operations for clinical research, independently managing submissions to IRBs, committees, sponsors, CROs, FDA, and regulatory agencies. He/She will oversee regulatory documentation, resolve complex compliance issues, direct study initiation, monitoring, audit, and close-out visits. He/She will serve as a liaison for regulatory oversight with investigational teams, nursing units, sponsors, and CROs. Other responsibilities include the development of regulatory tools and processes, providing expert regulatory and compliance guidance, and training/mentoring junior staff in regulatory practices and study oversight.
Perform additional regulatory duties as assigned.
Position is Contingent upon Grant Funding
Qualifications
Bachelor's degree and 5 to 7 years of experience or equivalent combination of education and experience is required.
Job Location - City, State
Philadelphia, Pennsylvania
Department / School
Perelman School of Medicine
Pay Range
$75,804.00 - $77,920.00 Annual Rate Salary offers are made based on the candidate’s qualifications, experience, skills, and education as they directly relate to the requirements of the position, and in alignment with salary ranges based on external market data for the job’s level. Internal organization and peer data at Penn are also considered.
Equal Opportunity Statement
The University of…