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University of Pennsylvania

Ivy League university in Philadelphia, PA

Clinical Research Coordinator B/C

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timePhiladelphia, PA, USA$53.4k - $63.1k /yr

About the Job

Requirements

  • Clinical Research Coordinator B requires a Bachelor of Science and 2 to 3 years of experience, or an equivalent combination of education and experience.
  • Clinical Research Coordinator C requires a bachelor’s degree and 4 to 6 years of experience, or an equivalent combination of education and experience.
  • Knowledge of Institutional Review Board and human research protection regulations is required.
  • Strong problem-solving abilities, written and verbal communication skills, and organizational and time-management skills are required.
  • Ability to manage multiple tasks while maintaining attention to detail, work independently and as part of a team, and adapt flexibly is required.

Responsibilities

  • Coordinate clinical trial activities to ensure trials follow protocols and regulatory requirements; maintain regulatory documents in accordance with sponsor, University of Pennsylvania, FDA, and Good Clinical Practice standards and guidelines; and prepare for and participate in study monitoring and audit visits.
  • Communicate with potential patients; prescreen, schedule, consent, and enroll patients; and ensure enrolled participants have documented eligibility checklists and signed the appropriate consent version.
  • Coordinate research visits; maintain source documentation; collect data and complete case report forms; and obtain, handle, process, transfer, and ship biospecimens when applicable.
  • Track adverse events and serious adverse events, maintain documentation and study logs, and coordinate with regulatory specialists when reports to regulatory entities are required, including reportable adverse events, serious adverse events, and deviations.
  • Conduct participant follow-up calls, track participants through study timepoints, upload data to relevant databases, perform data quality control, and address queries.
  • Review research billing, reimburse subjects when applicable, and document study-related training and essential 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 FDA guidelines.
  • For Coordinator C, independently manage assigned clinical trials with minimal supervision from the project manager.
  • For Coordinator C, act in a lead capacity coordinating Clinical Research Unit research team projects and assist Research Team Managers in overseeing project timelines and completion of study activities delegated to research coordinators A and B.
  • For Coordinator C, orient and mentor new staff and serve as a resource to current staff on study-related issues.

Desired Qualifications

  • Regulatory experience is preferred.
  • Radiation Oncology experience is preferred but not required.

About the Company

University of Pennsylvania

Ivy League university in Philadelphia, PA

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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