Clinical Research Coord 3

4 days ago

Toronto, Ontario, Canada HEALWELL AI (TSX: AIDX) Full time $80,000 - $120,000 per year

Duties And Responsibilities

  • Coordinates, executes and monitors all study activities to ensure conduct of clinical trials in accordance with study protocol, BPSI SOPs and/or Directives, ICH-GCPs and applicable regulatory guidelines. Typically, the studies assigned will be complex Bioequivalence/Bioavailability studies and potentially assist with complex Phase 1 studies
  • Review protocols and ICF
  • Attend SIV meetings
  • Generates Protocol and SOP deviations
  • Conducts protocol/ logistics training for clinical research staff
  • Performs compliance checks on subjects, as applicable
  • Reports Adverse Events and Serious Adverse Events to appropriate department(s)
  • Supervises, and assists in a drug administration
  • Assists with appropriate control, and record keeping of study drug(s), as required
  • Maintains study files for each clinical trial and performs a detailed review of documents prepared by Study Preparation Associates, including 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 of clinical research methodologies and regulatory requirements (FDA, TPD, etc.)
  • Prepares reports- study update, BSTD, demo AE tale, SSU
  • Follows up with subjects re: PSR, AES, unscheduled visits
  • Performs other tasks, as assigned, and as training and experience allow

Qualifications

  • Completed postsecondary 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
  • Weekend and evening requirements
  • 3+ years' work experience in a CRO (preferably in conducting Bioequivalence/ Bioavailability clinical trials)
  • Excellent problem solving, communication, multitasking and interpersonal skills
  • Detail oriented
  • Knowledge of Electronic Data Capture (EDC) systems is an asset.

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