University of Pennsylvania

Philadelphia, Pennsylvania

Duties: Coordinate clinical trials sponsored by the Translational Research Program or industry sponsors and conducted by the Clinical Trials Unit at the University of Pennsylvania. Coordination of trial activities will include but is not limited to obtaining informed consent, screening and enrollment of study participants, scheduling study related visits (e.g., lab tests and procedures), processing and shipping of study related specimens, scheduling of administration of investigational or study specified medications (e.g., study vaccines), completion of source documents and case report forms (CRFs), reporting of non-serious and serious adverse events, maintenance of regulatory files, preparation for monitoring visits and audits, assisting with the submission of study documents to all applicable institutional committees (e.g., IRB) for initial approval, continuing reviews and for approval of any amendments, and assisting Sponsor with annual IND reporting. Orient and mentor new research assistants and research coordinators. Function as resource to current research staff.

Qualifications: A Bachelor's degree and 2 years to 4 years of experience or equivalent combination of education and experience required.
Due to the complex nature of our clinical trials we are seeking candidates with effective problem solving abilities, communication and writing skills. Candidates should demonstrated ability to work as part of a team as well as independently.
Possess working knowledge of the Title 21 Code of Federal Regulations (CFR), International Conference of Harmonisation (ICH) and Good Clinical (Research) Practice (GCP) Guidelines.
Possess appropriate computer skills and working knowledge of Microsoft Office tools (e.g., Word, Excel, PowerPoint).

Reference Number: 40-30681

Salary Grade: 026

Employment Type: Exempt

Org: CI-Center for Cellular Immunotherapy

Special Requirements:

Job Family: I-Technical/Professional Research

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