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 setting 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, positive initiative and able to work with changing priorities.

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