SR CLINICAL RESEARCH REG COMPLIANCE SPEC
Duties: The Sr. Clinical Research Regulatory Compliance Specialist is an integral member of the Office of Clinical Research (OCR) in the Perelman School of Medicine and reports directly to the Executive Director of the OCR. Under the direction of the Executive Director and the Clinical Research Compliance Director, the Sr. Clinical Research Regulatory Compliance Specialist will work as part of the Compliance team to help support and facilitate clinical research at the University of Pennsylvania. The Sr. Clinical Research Regulatory Compliance Specialist will prospectively assess research programs and systematically conduct high quality compliance reviews, which include review preparation, conduct, close out and reporting, to ensure compliance with federal regulations and institutional policies. This position will interface with research faculty and staff, institutional offices, clinical departments and research institutes. In addition to compliance reviews, this position supports Principal Investigators and Clinical Research staff with IND/IDE exemption determinations and with the development of protocols, informed consents, case report forms, and other study documentation. Within the OCR, the Sr. Clinical Research Regulatory 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 Sr. Clinical Research Regulatory Compliance Specialist is also responsible for mentoring junior staff members within the compliance team.
Qualifications: * Education and experience equivalent to a Bachelor's degree and five to seven years work experience in clinical/translational research compliance and/or operations in any of the following areas: Academia, Pharmaceutical Company, Contract Research Organization (academic or private sector) or Site Management Organization (academic or private) required. Master's degree preferred.
* Direct experience in the following areas preferred:
- Compliance oversight for clinical trials; monitoring or auditing of studies
- Development of protocols, consent forms, and case report forms
- Clinical Research Coordinator/Project Management Experience
- 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: 40-25516
Salary Grade: 028
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: I-Technical/Professional Research