Job Description Summary
Renal division in the Department of Medicine supports a diverse group of investigators, involving work on a wide spectrum of clinical trials ranging from Phase I to IV, investigator and industry initiated trials. This position is responsible for study coordination for investigator-initiated studies, multi-center research studies, and patient-oriented clinical and translational research projects within the Renal, Electrolyte and Hypertension division. The position involves working directly with study physicians, research nurses and other research staff and at other sites.
The position will help advance the research mission of the Division and University and show vigilance in patient safety, protocol compliance, and data quality. It requires adherence to all University of Pennsylvania, IRB, and FDA guidelines and may require working offsite and flexible hours.
Job Responsibilities
Assist in the coordination of Phase I-IV clinical trials. Create, coordinate, organize, file, and maintain all documentation required by sponsor, CRO (source documentation, case report forms, study regulatory binders and patient binders).
Participate in new subject recruitment: identify, recruit, screen, consent, and enroll potential study participants. Escort participants for testing. Pick up and deliever specimens and supplies. Able to screen weekly PennChart schedule and EPIC reports to identify potential eligible participants that would meet study criteria for various studies.
Research data entry. Resolve data queries with sponsor and CROs. Enter data into electronic databases and perform chart extractions. Send reports and results to primary physicians. Obtain records or other material required to complete case report forms. Obtain materials required to complete case reports forms and comply with protocols.
Perform research testing such as: phlebotomy and vitals.
Perform additional administrative duties, such as ordering study supplies (kits, urine collection containers, stationery, etc) as required. Maintain logs, databases, spreadsheets.
Other duties as assigned.