DIRECTOR, PSOM CLINICAL RESEARCH COMPLIANCE
Duties: The Director, PSOM Clinical Research Compliance Program is an integral member of the Office of Clinical Research (OCR) in the Perelman School of Medicine (PSOM) with dual reporting to the University of Pennsylvania Research Compliance Officer and the Executive Director of the OCR. The Director will:
1) Direct PSOM's Clinical Research (CR) Compliance Program ensuring regulatory compliance across the research enterprise and provide senior level expertise and oversight for the support of 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, contribute to the education on employees, working closely with the sponsor support team, communicating effectivity with other related offices and audits of risk clinical research activities for GCP compliance and adherence for 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.
2) Lead the strategic planning, creation and implementation of the standard operating procedures across Penn Medicine and contribute to the University-wide Clinical Research Compliance Program standardization initiatives.
3) Responsible for the auditing activities of University-held INDs and IDEs, including providing oversight and leadership for the development of auditing schedules, review of compliance reports, adherence to protocol Data Safety and Monitoring Plans (DSMP)/Audit SOPs and identification of areas of risk and incorporation of risk mitigation plans into compliance activities.
4) Facilitate external audits, regulatory inspections, including FDA, NIH, Industry Sponsors, and follow clinical escalation procedures as applicable.
5) Author and/or contribute to auditing SOPs needed to conduct and oversee clinical trials.
6) Oversee and report on the management and compliance of PSOM clinicaltrials.gov submissions.
7) Responsible for supporting the facilitation and education of the PSOM research community in conjunction with all OCR units, the IRB, Office of Research Integrity, and the Abramson Cancer Center.
Qualifications: * Requires a MS in biomedical science, regulatory affairs, clinical research, nursing or related health sciences degree and a minimum of 5 years of monitoring or auditing experience 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 preferred. 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 skills with the ability to build and maintain effective professional relationships across the University.
Reference Number: 40-25343
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