CLIN RES REGULATORY COMPLIANCE SPECIALIST SR
Duties: The Senior Clinical Research Compliance Specialist is an integral member of the Office of Clinical Research (OCR) in the Perelman School of Medicine and reports directly to the Director of Compliance of the OCR. Under the management of the Director of Compliance, this position will plan, schedule and conduct regulatory compliance reviews of Penn Faculty and University held IND/IDE's and international regulatory filings. Compliance Reviews will focus on all aspects of clinical research execution to ensure activities are in compliance with applicable federal, international and local regulations, and established University of Pennsylvania policies and procedures.
This position will interface with the Perelman School of Medicine faculty and staff, institutional offices, clinical departments and research institutes. Within the OCR, the Senior Clinical Research Compliance Specialist will interface with other OCR Divisions to ensure the best support of research regulatory requirements, to assist with OCR research educational initiatives and to participate in research staff training. The candidate is also responsible for mentoring junior staff members within the compliance team.
Qualifications: A Bachelor's degree and 5 to 7 years of experience, or an equivalent combination of education and experience, are required. Degree in biomedical science, nursing or related health science is preferred. Master's Degree in advanced science is preferred; a minimum of 3-5 years of work experience in compliance oversight of clinical trials (monitoring, QA or auditing), study coordinator, project management, or combination thereof in any of the following environments: Academia, Pharmaceutical Industry, Contract Research Organizations (academic or private sector) or Site Management Organization (academic or private) required; an in-depth knowledge of and experience in the application of Good Clinical Practice (GCP) requirements is required (e.g., ICH, FDA, etc.). Familiarity with the essential documents related to clinical studies, medical terminology and routine medical tests and procedures preferred; familiarity with computerized clinical data collection systems and biomedical statistics is preferred; familiarity with Good Manufacturing Practices preferred; advanced knowledge of regulations governing human research, including 21 CFR Parts 11, 50, 54, 56, 312 and 812, 45 CFR 46, and ICH Good Clinical Practice guidelines; ability to respect and protect highly sensitive and confidential information.
Reference Number: 40-28083
Salary Grade: 028
Employment Type: Exempt
Org: SM-DN-Office of Clinical Research
Job Family: I-Technical/Professional Research