Social/Clinical Research Specialist

UNC-Chapel Hill•Chapel Hill, NC

About The Position

This position serves as a Clinical Research Coordinator within the Critical Care and Trauma Research Unit in the Department of Surgery. The coordinator plans, organizes, and conducts multiple clinical research study protocols, including consenting, independently collecting and recording data, project administration, clinical trial assessments, and appropriate follow-up. The role involves communicating with various stakeholders and ensuring trial activities follow the study protocol, regulatory requirements, and Good Clinical Practice (GCP) guidelines. The coordinator maintains complete, accurate, and up-to-date study documents, including regulatory binders, and reports adverse events or other significant occurrences to the appropriate parties. The position specializes in extracorporeal purification device trials, wound healing trials, and/or pharmacokinetic/pharmacodynamic clinical trials.

Responsibilities

  • Plan, organize, and conduct multiple clinical research study protocols.
  • Obtain participant consent.
  • Independently collect and record data.
  • Perform project administration and clinical trial assessments with appropriate follow-up.
  • Communicate with various stakeholders.
  • Ensure trial activities comply with study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines.
  • Maintain complete, accurate, and up-to-date study documents, including regulatory binders.
  • Report adverse events and other significant occurrences to appropriate parties.
  • Specialize in extracorporeal purification device trials, wound healing trials, and/or pharmacokinetic/pharmacodynamic clinical trials.
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