Clinical Research Coordinator

Richardson, TX 75080
Full-time


The Clinical Research Coordinator is responsible for managing the daily operations of a clinical investigation. This position will manage multiple, sponsored (Phase I, II, III and IV) clinical trials for many indications within psychiatry.

The Essential Job Functions are :

  • Maintain a detailed knowledge of all study protocols in order to complete all study activities correctly and completely
  • Recruit and screen patients for assigned studies
  • Provide instructions and education to subjects to ensure proper protocol compliance
  • Complete visit procedures including, but not limited to, obtaining vital signs measurements, performing ECG’s, and collecting blood samples for processing and shipment to the appropriate lab facility
  • Notify the Investigator of all adverse events
  • Report all serious adverse events in compliance with FDA regulations and sponsor requirements
  • Provide the Sponsor with accurate and complete documentation and information
  • Complete and maintain accurate, legible and complete source documents and case report forms per FDA guidelines and Sponsor requirements
  • Prepare for FDA audit by ensuring all documentation and case report forms are available and complete. Ensure the rights, safety and welfare of all subjects at all times
  • Ensure that each subject has completed the informed consent process, following GCP guidelines, and has consented to participate before any study related procedures are performed
  • Provide subjects education on an ongoing basis throughout their participation in the protocol
  • Report all adverse events to the Investigator, Sponsor and IRB
  • Complete all relevant site-level and study-level logs in a timely manner
  • Utilize a team approach including the PI, Sub-Investigators, Site Manager, other Coordinators and Research Assistants
  • Act as a liaison to ensure complete and accurate communication between physicians, sponsors and subjects. Work in a collaborative, effective manner with the Sponsor to meet research objectives
  • Understand and comply with all internal policies and procedures approved by the Medical Director, Site Manager, and any other departments

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