U

University of Pennsylvania

Ivy League university in Philadelphia, PA

Clinical Research Coordinator C

Full-Time
$63.1k/yr
Mid
Bachelor's
Philadelphia, PA, USA
In Person

About the job

Requirements
  • A Bachelor of Science degree and 4 to 6 years of experience, or an equivalent combination of education and experience, is required.
  • Prior experience coordinating Phase I-IV clinical trials is required.
Responsibilities
  • Serve as a resource for best practices in managing major clinical trials, including study and device trials.
  • Act as a liaison among the investigational team, sponsors, and departmental stakeholders.
  • Oversee implementation of new clinical trials and review new trials to identify challenges and opportunities.
  • Develop action plans to solve trial implementation challenges.
  • Work with the regulatory manager to ensure timely submissions to the Institutional Review Board.
  • Supervise trial execution with staff to ensure protocol adherence and audit trials for compliance and enrollment.
  • Review data entry for accuracy and completeness and manage adverse events.
  • Prepare for trial audits and inspections and lead trial inspections.
  • Provide bi-weekly updates to the research team and principal investigator.
  • Coordinate Phase I-IV clinical trials.
  • Recruit, consent, and screen patients according to protocol.
  • Schedule patient visits and necessary testing, monitor patients according to protocol requirements, and ensure adherence to protocols.
  • Organize and maintain source documentation, case report forms, research charts, and other required documentation.
  • Collect, review, and report study data; complete case report forms and resolve data queries.
  • Process and ship blood, urine, and tissue study specimens.
  • Participate in study initiation, monitoring, audit, and close-out visits.
  • Participate in study team, site group, protocol training, and compliance meetings.
  • Assist project managers with study start-up, including coordination with finance and legal teams to complete clinical trial agreements and budgets.
  • Develop and maintain study-specific case report forms and source-document tools.
  • Prepare and process regulatory documentation through the Institutional Review Board, Clinical Trials Scientific Review and Monitoring Committee, Food and Drug Administration, and other applicable review bodies.
  • Assist project managers in training new staff.

About the company

U

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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