Clinical Research Coordinator

3 weeks ago


Reston, Virginia, United States Kelly Science, Engineering, Technology & Telecom Full time

Clinical Study Assistant Job Summary

Kelly Science, Engineering, Technology & Telecom is seeking a highly organized and detail-oriented Clinical Study Assistant to provide administrative and organizational support for assigned clinical trials and sites in accordance with Good Clinical Practice (GCP), guidelines, standards, federal regulations and SOPs.

Key Responsibilities:

  • Support investigative sites toward completion and appropriate submission of all required clinical trial documents prior to site initiation.
  • Establish and maintain the electronic Trial Master Files (eTMF) for assigned clinical trials.
  • Coordinate Institutional Review Board/Ethics Committee (IRB/EC) approvals, as appropriate.
  • Support overall progress of clinical trials by regularly attending clinical trial team meetings, reviewing team communications and sharing pertinent information with assigned investigative sites.
  • Assist with study startup procedures, including preparing site binders.
  • Ensure all equipment/supplies provided to investigative sites is appropriately tracked and reported to Study Manager and/or Lead CRA.
  • Assist with contracts and purchase orders.
  • Prepare, submit and file quality monitoring visit reports and associated follow-up letters in a timely manner.
  • Provide regular updates to the Investigator of assigned investigative sites, Study Manager and/or Lead CRA with respect to study conduct and compliance.
  • Maintain audit/inspection readiness at assigned sites throughout the conduct and upon closure of clinical trials at assigned investigative sites.
  • Support study payment activities or accruals, as assigned.


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