CLINICAL RESEARCH COORDINATOR

Duke University-posted 4 months ago
$59,829 - $99,960/Yr
Full-time • Entry Level
Durham, NC
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Duke University School of Medicine is the youngest of the nation's top medical schools, established in 1930 and ranked sixth among medical schools in the nation. The School prides itself on being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced. The position involves working within the BioRepository & Precision Pathology Center (BRPC), handling clinical trials, consenting patients, and managing retrospective projects involving accessing archival tissue from Duke. The candidate should possess strong organizational and communication skills.

  • Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties.
  • Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs.
  • Prepares for and provides support for study monitoring and audit visits, including support for the reviewer.
  • Maintains participant level documentation for all studies, including those that are complex in nature.
  • Employs and may develop strategies to maintain recruitment rates and evaluate processes to identify problems.
  • Screens participants for complex studies.
  • Develops or helps develop SOPs.
  • Collects, prepares, processes, ships, and maintains the inventory of research specimens.
  • Schedules participants for research visits and prepares necessary documents, equipment, supplies, etc.
  • Conducts and documents non-complex visits and scripted testing or interviews.
  • Identifies all AEs, and determines whether or not they are reportable.
  • Collaborates with the PI to determine AE attributes, including relatedness to study.
  • Conducts and documents consent for participants for all types of studies.
  • Develops consent plans and documents for participants in a variety of studies.
  • Develops and submits documentation and information for IRB review.
  • Enters and collects data, ensuring accuracy and completeness.
  • Independently conducts literature searches and reviews.
  • Prepares for, coordinates, and actively participates in site visits.
  • Communicates effectively with sponsors and/or CROs.
  • Ensures that studies are conducted in compliance with institutional requirements and other policies.
  • Works with the manager to understand areas of opportunity and develop a training plan.
  • Completion of an Associate's degree.
  • Minimum of two years of relevant research experience.
  • A Bachelor's degree may substitute for 2 years required experience.
  • Comprehensive and competitive medical and dental care programs.
  • Generous retirement benefits.
  • Wide array of family-friendly and cultural programs.
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