Position Reports To: Supervisor, Clinical Research

Position Summary:

  • Coordinates, executes and monitors all study activities to ensure conduct of clinical trials in accordance to study protocol, BPSI SOPs and/or Directives, ICH-GCPs and applicable regulatory guidelines
  • CRCA assists CRCs with Study related duties
  • Conducts protocol training for clinical research staff
  • Performs compliance check on subjects as applicable
  • Reports Adverse Events and Serious Adverse Events to appropriate department(s)
  • Supervises, administers and/or assists in a drug administration
  • Assists with dispensing, appropriate control, inventory, storage and record keeping of study drug(s) as required
  • Maintains study files for each clinical trial and performs detailed review of created and prepare by Study Preparation Associates subject and study source documentation and/or CRFs, as well as of completed Source Documents and CRFs
  • Participates in development, revision and implementation of clinical, general and other applicable SOPs, Directives and internal procedures as required, ensuring consistency with GCP, regulatory, and/or Sponsor requirements
  • Ensures the accuracy of the generated data in accordance with protocols, ICH, GCP and applicable regulatory agencies
  • Maintains adequate, accurate, complete and legible records
  • Collaborates with QC and QA during audits and audit Follow-ups Maintains current professional knowledge base of clinical research methodologies and regulatory requirements (FDA, TPD, etc.)
  • Participate in staff training sessions
  • Performs other tasks as assigned and as training and experience allow


  • Completed post secondary degree in a science or healthcare related discipline, or equivalent work experience.
  • Certification in Clinical Research is an asset.
  • Flexible hours depending on business requirements.
  • Rotating shifts and weekend requirements.
  • 1-2 years work experience in a CRO (preferably in conducting Phase I /Bioequivalence clinical trials)
  • Excellent problem solving, communication, multitasking and interpersonal skills
  • Excellent in Microsoft Word and Excel.