"Clinical Research Quality Specialist B (Department of Office of Clinical Research)"

The Clinical Research Quality Specialist is an integral member of the Office of Clinical Research (OCR) in the Perelman School of Medicine and reports directly to the Associate Director, PSOM Office of Clinical Research Compliance. The Clinical Quality Specialist will work as part of the Compliance team to help support and facilitate clinical research at the University of Pennsylvania. The Clinical Research Quality 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. Within the OCR, the Clinical Research Quality 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.

Job Responsibilities:

• Assist in the facilitation and conduct of compliance reviews for assigned Sponsor and Investigators, including preparation, reporting and close out.
• Provide support to Investigators and research staff in the development of research protocols, informed consent forms, case report forms, and other related study documentation.
• Conduct training of Investigators, Sponsors and Clinical Research Staff in areas related to clinical research.
• Support other OCR divisions as needed: IND/IDE Unit, Operations, Billing, Clinical Contracting.
• Assist in other system-wide compliance related oversight initiatives (i.e., PICA tracking, training tracking, Ct.gov tracking and maintenance).
• Perform additional duties as assigned.

Qualifications:

• Bachelor's degree and 3-5 years of experience. Experience in clinical/translational research compliance and/or operations in any of the following areas: academia, pharmaceutical, contract research organization (academic or private sector), or site management organization (academic or private).
• 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.

Cover letter and resume required with application.

Targeted Pay Range: $69,953-77,123. This is based on the candidate's qualifications, experience, skills, and education.

University Benefits include health, life, and flexible spending accounts; tuition benefits; retirement plans; time away from work; long-term care insurance; wellness and work-life resources; professional and personal development; university resources; discounts and special services; flexible work hours; Penn home ownership services; and adoption assistance.