CLINICAL RES REGULATORY COMPLIANCE SPEC

Duties: The Clinical Research Monitoring Specialist is an integral member of the Office of Clinical Research (OCR) in the Perelman School of Medicine and reports directly to the Director, PSOM Clinical Research Audit and Compliance. The Clinical Research Monitoring Specialist will work as part of the Compliance team to help support and facilitate clinical research at the University of Pennsylvania. The Clinical Research Monitoring Specialist will work with senior team members to facilitate and 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 investigators and staff throughout the review process. In addition to compliance reviews, this position will assist in the development of protocols, informed consents, case report forms, and other study documentation for Principal Investigators as needed. Within the OCR, the Clinical Research Monitoring Specialist will interface with other OCR units to ensure the best support of research regulatory requirements, to assist with OCR research educational initiatives and to participate in research staff training.

Qualifications: * Bachelor's degree and at least three years of 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), on an equivalent combination of education and experience required
* 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
- Coordination of clinical research studies
- 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: 40-26502

Salary Grade: 027

Employment Type: Exempt

Org: SM-DN-Office of Clinical Research

Special Requirements:

Job Family: I-Technical/Professional Research