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Clinical Research Coordinator B (Dept. of Surgery)

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University of Pennsylvania

Philadelphia, PA 19104, USA

3 Star Employer Ranking

Clinical Research Coordinator B (Dept. of Surgery)

Clinical Research Coordinator B (Dept. of Surgery)

Job Description Summary

This position's primary function is to facilitate, promote, and ensure good clinical practice in the conduct of all research protocols in the Department/Center. Independently manages different phases of complex clinical trials and mentors coordinators and research assistants. Works with partnering institutions and creates multi-center budgets and manages expenses. Participates in study team meetings, disease site group meetings, and ongoing protocol training/compliance meetings. Supports in the monitoring of external sites and assists in the management of multisite trials.

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.
  • 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

Qualifications

Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required.

This position is contingent upon grant funding.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$52,500.00 - $52,661.00 Annual Rate

Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, and in alignment with salary ranges based on external market data for the job's level. Internal organization and peer data at Penn are also considered.

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