DIRECTOR, PSOM CLINICAL RESEARCH COMPLIANCE
Duties: The Director of the Clinical Research Compliance Program is an integral member of the Office of Clinical Research (OCR) in the Perelman School of Medicine (PSOM) reporting to the Vice Dean for Clinical Research. The position is responsible for implementing and maintaining a compliance program and operationalizing the components of the program in alignment with applicable laws and regulations and PSOM and University policy.
The Director is responsible for directing PSOM's Clinical Research (CR) Compliance Program to ensure regulatory compliance across the research enterprise and provide senior level expertise and oversight for quality systems regarding all GCP activities. The Director will provide recommendations for clinical research best practice to the Senior Associate Vice Provost for Human Research, the Vice Provost of Research, the Institutional Review Board, the University Office of Research Integrity and the University Research Compliance Committee. The PSOM Compliance Program consists of setting best practices for clinical research conduct, contributing to the education of employees, working closely with the sponsor support team, communicating effectively with other related offices and auditing of clinical research activities for GCP compliance and adherence to fCOI management plans. Responsible for risk management activities for PSOM clinical trials, including leadership and contribution to the development of risk management and corrective action plans.
Qualifications: Requires a MS in biomedical science, regulatory affairs, clinical research, nursing or related health sciences degree and a minimum of 5 to 7 years of experience leading a compliance program with increasing responsibilities including team management, in one or more of the following areas, Academic Health Center, Pharmaceutical Industry, Contract Research Organization or Site Management Organization or an equivalent combination of education and experience. JD or PhD and/or additional years of qualifying experience strongly preferred. Previous monitoring or auditing experience required. RAPs certification preferred.
Experience with FDA/federal agency inspections highly preferred.
Advanced knowledge of federal research regulations and guidance, including but not limited to 21CFR Parts 11, 50, 54, 56, 312 and 812, 45 CFR 46 and ICH GCP guidance as well NIH, Conflict of Interest and CMS regulations and guidance.
Superior interpersonal and leadership skills with the ability to build and maintain effective professional relationships across a matrixed organizational structure in the health system, the PSOM and the University.
Ability to provide clear, pragmatic direction and advice regarding compliance issues.
Reference Number: 40-28262
Salary Grade: 030
Employment Type: Exempt
Org: SM-DN-Office of Clinical Research
Special Requirements: Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
Job Family: B-Executive/Managerial Administration