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Clinical Research Coordinator A/B (Dept. of Surgery)

University of Pennsylvania · Philadelphia, PA · 5 mo ago
Analyst$47k–$53k/yrFull-time

About the role

The University of Pennsylvania is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.

Responsibilities

  • CRC-A: Coordinate and conduct clinical studies, includes; subject recruitment, informed consent, chart maintenance and data entry
  • CRC-A: Coordinate IRB submissions and renewals in accordance with FDA and IRB guidelines
  • CRC-A: Ensure compliance with the protocol and regulatory requirements includes: collecting, recording, and maintaining data and source documentations
  • CRC-A: Oversee study preparation and blood sample processing and analysis
  • CRC-A: Database management and analysis
  • CRC-A: Ordering and stocking supplies, maintaining equipment
  • CRC-A: Educate patients and family members
  • CRC-A: Promote good clinical practice in the conduct of clinical investigations
  • CRC-B: Prepare and process all Institutional Review Board (IRB) through the IRB and other regulatory groups as appropriate including initial submissions, amendments, continuing reviews, adverse events and serious adverse events
  • CRC-B: Assist in the coordination of Phase I-IV clinical trials
  • CRC-B: Participate in the conduct of study audits by sponsors, CRO's, the FDA and other entities as required
  • CRC-B: Schedule patient visits and any necessary testing
  • CRC-B: Adhere to all University of Pennsylvania, ICF, and FDA guidelines
  • CRC-B: Process and ship blood, urine and tissue as required per trial
  • CRC-B: Conduct initiation, monitoring and closeout visits with sponsors and/or CROs
  • CRC-B: Ensure proper screening and enrollment of all study participants, including administering informed consent and confirming subject study eligibility prior to participation

Qualifications

  • Bachelor of Science and 1 to 2 years of experience or equivalent combination of education and experience is required. (CRC-A)
  • Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required. (CRC-B)

Skills

  • Excellent communication and organizational skills
  • Ability to manage multiple projects simultaneously
  • Strong attention to detail
  • Proficiency in Microsoft Office Suite
  • Knowledge of Good Clinical Practice (GCP) guidelines

Benefits

The University of Pennsylvania offers a comprehensive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.

Pay

$47,313.00 - $53,418.00 Annual Rate

Schedule

Contingent upon grant funding.

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