Clinical Research Coordinator B

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Posted Job Title

Clinical Research Coordinator B

Job Profile Title

Clinical Research Coordinator B

Job Description Summary

The primary role of the Clinical Research Coordinator B (CRC-B) is to coordinate breast cancer investigator-initiated studies and patient-oriented clinical and translational research projects led by Drs Rachel Jankowitz and Saya Jacob within the breast clinical research department. The CRC-B works directly with study physicians and other research staff. This position will be responsible for 1) communicating study information to research participants, answering patient questions, consenting and enrolling participants onto research studies, 2) coordinating study activities: tracking patient referrals, screening patients for eligibility, scheduling study visits and procedures, ensuring all biospecimens are collected, processed, and shipped and/or submitted per protocol requirements, 3) tracking enrolled study participants throughout the protocol follow up period and coordinating follow up procedures per protocol windows, 4) organizing and maintaining subject research charts, ensuring study documentation is complete and accurate, and entering study data into study databases. 5)Reviewing patient charts and extracting pre-specified clinical data as well as entering extracted data 6) Help to clean up and do basic analysis of data sets. 7)Assistance with drafting research proposals and reports. The position requires a motivated, articulate individual with excellent oral and written communication skills. The candidate should possess the ability to work independently and as part of a team.

Job Description

Job Responsibilities

• Prepare and process all Institutional Review Board (IRB)through the IRB and other regulatory groups as apropriate including initial submissions, amendments, continuing reviews, adverse events and serious adverse events
• Coordinate, organize and maintain all documentation required by sponsor or CRO (case report forms, source documentation, study and regulatory binders, subject binders)
• Assist in the coordination of Phase I-IV clinical trials
• Participate in the conduct of study audits by sponsors,CRO's, the FDA and other entities as required.
• Participate in the conduct of study audits by sponsors, CRO's, the FDA and other entities as required.
• Schedule patient visits and any necessary testing.
• Adhere to all University of Pennsylvania, ICF, and FDA guidelines.
• Process and ship blood, urine and tissue as required per trial
• Conduct initiation, monitoring and closeout visits with sponsors and/or CROs
• Ensure proper screening and enrollment of all study participants, including administering informed consent and confirming subject study eligibility prior to participation
• Other duties and responsibilities as assigned

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