About The Position

Report to the Clinical Research Supervisor, Clinical Research Manager, or Director of Clinical Research Operations; serve as Clinical Research Coordinator III (CRC-III) responsible for all aspects of clinical research activities while collaborating with study physicians, inter- and intradepartmental stakeholders, and sponsors. Manage complex clinical research trials—including drug, device, and biologic studies—across industry-sponsored Phase I–IV trials, government-funded research, and investigator-initiated studies. Provide comprehensive study management, support, and coordination for FDA-regulated research: conduct protocol review, administer informed consent, recruit subjects, collect accurate data, complete case report forms (CRFs), report adverse events, and oversee scheduled subject follow-up. Oversee all facets of the clinical research process, including development of study treatment plans, completion of visit forms, and verification that all protocol-required assessments are performed. Ensure timely and accurate completion of CRFs, adverse event/serious adverse event (SAE) reporting, subject follow-up, and maintenance of regulatory binders. Assist with training other CRCs; collaborate with Clinical Research and Institute leadership to optimize processes, operationalize, and maintain early therapeutics, immunotherapy, and other trials. Develop study flow sheets; prepare source documentation; gather study data; assess subject eligibility; record protocol-specific assessments and treatments; coordinate sample collection and shipment; enter and clean data in study databases; host study team meetings; attend site-initiation visits (SIVs); and perform other duties as assigned.

Responsibilities

  • Manage complex clinical research trials—including drug, device, and biologic studies—across industry-sponsored Phase I–IV trials, government-funded research, and investigator-initiated studies.
  • Provide comprehensive study management, support, and coordination for FDA-regulated research: conduct protocol review, administer informed consent, recruit subjects, collect accurate data, complete case report forms (CRFs), report adverse events, and oversee scheduled subject follow-up.
  • Oversee all facets of the clinical research process, including development of study treatment plans, completion of visit forms, and verification that all protocol-required assessments are performed.
  • Ensure timely and accurate completion of CRFs, adverse event/serious adverse event (SAE) reporting, subject follow-up, and maintenance of regulatory binders.
  • Assist with training other CRCs; collaborate with Clinical Research and Institute leadership to optimize processes, operationalize, and maintain early therapeutics, immunotherapy, and other trials.
  • Develop study flow sheets; prepare source documentation; gather study data; assess subject eligibility; record protocol-specific assessments and treatments; coordinate sample collection and shipment; enter and clean data in study databases; host study team meetings; attend site-initiation visits (SIVs); and perform other duties as assigned.
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