Full-Time

Clinical Research Coordinator

Department of Surgery

University of Pennsylvania

University of Pennsylvania

Ivy League university in Philadelphia, PA

Compensation Overview

$47.3k - $53.4k/yr

Philadelphia, PA, USA

In Person

Bachelor's

Category
Biology & Biotech (1)
Required Skills
Data Analysis
Patient Education

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Requirements
  • A Bachelor of Science and 1 to 2 years of experience, or an equivalent combination of education and experience, is required for Clinical Research Coordinator A.
  • A Bachelor of Science and 2 to 3 years of experience, or an equivalent combination of education and experience, is required for Clinical Research Coordinator B.
  • Possess in-depth knowledge of federal regulations and guidance documents for the conduct of clinical studies and human subject protection.
  • Adhere to University of Pennsylvania, ICF, and Food and Drug Administration guidelines.
Responsibilities
  • Coordinate and conduct clinical studies, including subject recruitment, informed consent, chart maintenance, and data entry.
  • Coordinate Institutional Review Board submissions and renewals in accordance with Food and Drug Administration and Institutional Review Board guidelines.
  • Assure compliance with the protocol and regulatory requirements by collecting, recording, and maintaining data and source documentation.
  • Oversee study preparation and blood sample processing and analysis.
  • Manage and analyze databases.
  • Order and stock supplies and maintain equipment.
  • Educate patients and family members.
  • Promote good clinical practice in the conduct of clinical investigations.
  • Prepare and process Institutional Review Board submissions through the Institutional Review Board and other regulatory groups, including initial submissions, amendments, continuing reviews, adverse events, and serious adverse events.
  • Coordinate, organize, and maintain documentation required by sponsors or contract research organizations, including case report forms, source documentation, study and regulatory binders, and subject binders.
  • Assist in coordinating Phase I-IV clinical trials.
  • Participate in study audits conducted by sponsors, contract research organizations, the Food and Drug Administration, and other required entities.
  • Schedule patient visits and necessary testing.
  • Process and ship blood, urine, and tissue as required per trial.
  • Conduct initiation, monitoring, and closeout visits with sponsors or contract research organizations.
  • Ensure proper screening and enrollment of study participants, including administering informed consent and confirming subject study eligibility before participation.
University of Pennsylvania

University of Pennsylvania

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The University of Pennsylvania is a private Ivy League research university in Philadelphia. It comprises twelve undergraduate, graduate, and professional schools, including the Wharton School, Perelman School of Medicine, and Penn Carey Law.

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