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Clinical Trial Documentation Associate in Toronto, Ontario at WELL Health Technologies Corp

NewSalary: $53000 - $55000
WELL Health Technologies Corp
Toronto, Ontario, M9L 3A2, Canada
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Job Description

Company: BioPharma Services Inc.

Position Title: Clinical Trial Documentation Associate

Hourly Rate: $53,000 to $55,000

Job Class: Full-time, 40 hours per week

Work Location: Onsite (North York)


Duties and Responsibilities:

  • Prepare and maintain the ISF and/or TMF, as applicable, in collaboration with clinic staff, and other applicable departments ensuring the ongoing collection and filing of essential documents using a paper-based, hybrid, or Veeva-based system.
  • Assist with archiving CSR:
  • Coordinates, prepares, and submits appropriate documents to the Research Ethics Board for review and approval (e.g., Protocol, Investigators Brochures, Informed Consent Forms, Telephone screens, subject information sheets, and advertisements)
  • Tracks the approval process and updates study team members on the approval status of all clinical trials
  • Submits revised and additional materials to the Research Ethics Board (e.g. amendments, advertisements, safety/study status updates, and close out reports) as required
  • Reviews and files approval documentation from the Research Ethics Board in the ISF and/or TMF and on the Study Specific Directory.
  • Assist with the compilation, completion, and internal approval process of Regulatory documentation (Qualified Investigator Undertaking, FDA 1572, financial disclosure, etc.) and provide completed Regulatory documentation to Sponsor/CRO for each study.
  • Compile study documents.
  • Ensure accurate and complete documentation of all clinic study source documents, case report forms (CRF) and/or forms according to company’s SOP, GCP and other guidelines.
  • Perform other duties as required.

    • Qualifications:

  • BSc, BA, or equivalent experience
  • Administrative experience in clinical trials,
  • Experience in CRO environment preferably in conduct of Phase I and Bioequivalence studies
  • Experience in Research Ethics Boards, Investigator Site File (ISF) and Trial Master File (TMF) is an asset.
  • Experience is preparing the source documents for clinical trials is an asset.
  • Excellent interpersonal skills and communication skills.
  • Excellent organization, multi-tasking skills
  • Attentive to details, good initiative and able to work with changing priorities.

    • Job Location

    Toronto, Ontario, M9L 3A2, Canada

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