The University of Texas System - Galveston, TX

posted about 2 months ago

Full-time
Galveston, TX
Educational Services

About the position

The Clinical Research Coordinator at UTMB Health plays a vital role in supporting clinical research activities within the Cardiovascular Medicine department. This position involves obtaining human subject data, ensuring compliance with study protocols, and performing various administrative duties to facilitate research operations. The coordinator will work closely with healthcare professionals, manage participant records, and assist in the preparation and submission of research protocols.

Responsibilities

  • Obtain human subject data for clinical research activities as per study protocol.
  • Schedule, coordinate, and participate in pre-site and site initiation visits.
  • Maintain and monitor source documentation and participant records for quality and accuracy.
  • Assist in reviewing patient eligibility and collecting relevant data from external sources.
  • Reconcile study drug accountability and maintain temperature and QC logs as per protocol compliance.
  • Develop and maintain productive relationships with study monitors and participate in coordinator workshops.
  • Identify and recruit clinical research subjects, collect data, and monitor enrollment goals.
  • Mentor new clinical research coordinators and assistant coordinators.
  • Assist with grant/protocol preparation and submission to IRB, OCR, or OSP under the direction of the PI.
  • Draft communications with sponsors and regulatory documents as directed by the PI.
  • Assist in planning and designing source documents for protocols.
  • Assist in developing procedures for laboratory collection and storage.
  • Process and ship lab specimens efficiently and maintain supply inventory.
  • Assist with budget development and monitor ledgers.
  • Obtain informed consent from study participants when appropriately trained.

Requirements

  • Bachelor's degree or equivalent.
  • Two years of directly related experience in clinical research.

Nice-to-haves

  • Experience with Good Clinical Practice (GCP) activities.
  • Familiarity with IRB submission processes.
  • Ability to perform phlebotomy and obtain vital signs.

Benefits

  • Competitive salary commensurate with experience.
  • Equal opportunity employment policies.
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