Full-Time

Clinical Research Coordinator B/C

University of Pennsylvania

University of Pennsylvania

Ivy League university in Philadelphia, PA

Compensation Overview

$53.4k - $63.1k/yr

Philadelphia, PA, USA

Hybrid

Hybrid eligibility begins after the introductory period and six months of service.

Bachelor's

Category
Biology & Biotech (1)

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Requirements
  • A Bachelor of Science degree and 2 to 3 years of experience, or an equivalent combination of education and experience, is required for Clinical Research Coordinator B.
  • A bachelor's degree and 4 to 6 years of experience, or an equivalent combination of education and experience, is required for Clinical Research Coordinator C.
  • Strong problem-solving abilities are required.
  • Excellent written and verbal communication skills are required.
  • Solid organizational and time management skills are required.
  • The candidate must be able to manage multiple tasks while maintaining strong attention to detail.
  • The candidate must be capable of working independently and as part of a team.
  • Knowledge of Institutional Review Board and human research protection regulations is required.
Responsibilities
  • Coordinate trial-related activities to ensure execution adheres to the protocol and regulatory requirements, maintain regulatory documents per sponsor, University of Pennsylvania, Food and Drug Administration, and Good Clinical Practice standards and guidelines, and prepare for and participate in study monitoring and audit visits.
  • Communicate with potential patients, pre-screen, schedule, consent, and enroll patients, and ensure enrolled subjects have documented eligibility checklists and signed appropriate versions of consent.
  • Coordinate research visits, maintain source documentation, collect data, complete case report forms, and obtain, handle, process, and transfer or ship biospecimens when applicable.
  • Track adverse events and serious adverse events, maintain documentation and study logs, and coordinate with the regulatory specialist when reports are needed, including reportable adverse event or serious adverse event deviations.
  • Conduct follow-up phone calls with participants, track participants through required timepoints, upload data to relevant databases, perform data quality control, and address queries.
  • Perform research billing review and subject reimbursement when applicable, and document all training and essential study-related correspondence.
  • Attend study-related and other required meetings, and maintain or order study materials as needed.
  • Adhere to University of Pennsylvania, informed consent form, and Food and Drug Administration guidelines.
  • For the Coordinator C level, independently manage assigned clinical trials with minimal supervision from the project manager.
  • For the Coordinator C level, act in a lead capacity in coordinating Clinical Research Unit research team projects and assist Research Team Managers in overseeing project timelines and completion of study-related activities delegated to research coordinators A and B.
  • For the Coordinator C level, orient and mentor new staff and act as a resource to current staff members on study-related issues.
Desired Qualifications
  • Regulatory experience is preferred.
  • Radiation Oncology experience is preferred but not required.
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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