Clinical Research Coordinator B/C (Department of Gastroenterology)

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Posted Job Title

Clinical Research Coordinator B/C (Department of Gastroenterology)

Job Profile Title

Clinical Research Coordinator B

Job Description Summary

This position is responsible for initiating and managing 5-6 clinical research trials across all phases, evaluating new medications and devices in Gastroenterology Research. The Clinical Research Coordinator B/C will work under minimal supervision of the Principal Investigator and Associate Director. Independently manage different phases of clinical trials and mentor coordinators and research assistants. The role will span industry-sponsored, investigator-initiated, and NIH-funded research across two sites: PCAM and PPMC. The coordinator will actively participate in study team meetings, ongoing protocol training, and compliance activities. The position requires a strong commitment to patient safety, protocol adherence, and data quality, ensuring compliance with all University of Pennsylvania, FDA, and GCP guidelines.

Job Description

Job Responsibilities

Clinical Research Coordinator B

• Ensure preparation of all required study related documents for submission to all applicable PENN institutional committees for review and approval to start trial (e.g., IRB, CTSRMC) as well as Central IRB
• Coordinate, organize and maintain all documentation required by sponsor/CRO (case report forms, source documentation, regulatory binders, subject binders)
• Support and manage the coordination of Phase I-IV clinical trials
• Coordinate and organize study audits by sponsors,CRO's, the FDA and other entities as required
• Manage scheduling and coordination of subject study visits, specified treatments and procedures 
• Process and ship blood, urine and tissue as required per trial
• Conduct initiation, interim, monitoring and closeout visits with sponsors and/or CROs
• Ensure proper screening and enrollment of all study participants, including administering