CLINICAL RESEARCH COORD A
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 1 year to 3 years of experience or equivalent combination of education and experience required. Demonstrated capacity/ability from past work experience to learn and apply new concepts, develop skills and knowledge, work/collaborate with others, work independently, organize, prioritize, problem solve and utilize resources appropriately.
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: 40-27763
Salary Grade: 025
Employment Type: Exempt
Org: CI-Center for Cellular Immunotherapy
Job Family: I-Technical/Professional Research