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 workplace 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.

📌 Clinical Trial Documentation Associate (Toronto)
🏢 WELL Health Technologies
📍 Toronto