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University of Pennsylvania

Ivy League university in Philadelphia, PA

Clinical Research Coordinator A/B/C

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timePhiladelphia, PA, USA$47.3k - $67k /yrIn-person

About the Job

Requirements

  • Clinical Research Coordinator A requires a Bachelor of Science and 1 to 2 years of experience, or an equivalent combination of education and experience.
  • 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 of Science and 4 to 6 years of experience, or an equivalent combination of education and experience.

Responsibilities

  • Screen, recruit, consent, and enroll research participants according to study protocols, Good Clinical Practice guidelines, and institutional requirements, and conduct ongoing participant follow-up and compliance monitoring.
  • Conduct study visits and research procedures, including collecting medical history, vital signs, electrocardiograms, and specimens and processing specimens, and maintain accurate study documentation, source records, study data, and regulatory files in compliance with Good Clinical Practice, sponsor, and institutional requirements.
  • Collaborate with Regulatory Affairs staff and study teams to prepare for sponsor, contract research organization, Food and Drug Administration, and internal audits or monitoring visits; assist with regulatory binder maintenance, quality assurance, resolution of monitoring findings, and data queries.
  • Assist with preparing and submitting regulatory documents to the Institutional Review Board, sponsors, and other regulatory entities, including protocols, amendments, continuing reviews, adverse event reports, and study-related correspondence.
  • Clinical Research Coordinator A may assist with training research support staff on study-specific procedures and workflows, attend investigator meetings and communicate relevant study updates, and, with supervision, assist in preparing and maintaining source documents, study trackers, research records, and study-specific tools.
  • Clinical Research Coordinator B assists, with leadership guidance, in coordinating and organizing research support staff activities related to recruitment, study visits, regulatory maintenance, and data collection; attends investigator meetings and communicates updates to the study team; and, with limited supervision, develops and maintains source documents, study trackers, case report forms, consent documents, and other moderately complex study materials and tools.
  • Clinical Research Coordinator C independently develops, maintains, and oversees complex study documents, operational workflows, trackers, consent forms, and study management tools, and assists with protocol implementation and study execution activities; may provide day-to-day operational guidance, mentorship, and training to junior coordinators or research support staff, assist with workflow oversight, and lead study-related communications and meetings.
  • Perform other duties and responsibilities as assigned.

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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