Clinical Trial Documentation Associate

WELL Health Technologies Corp • Toronto, ON

3d • CA$53,000 - CA$55,000 • Onsite

About The Position

BioPharma Services Inc. is seeking a Clinical Trial Documentation Associate to join their team. This full-time, onsite position in North York involves preparing and maintaining essential documents for clinical trials, coordinating with various departments, and ensuring compliance with company SOPs, GCP, and other guidelines. The role requires strong organizational and communication skills, attention to detail, and the ability to manage changing priorities.

Requirements

• BSc, BA, or equivalent experience
• Administrative experience in clinical trials
• Excellent interpersonal skills and communication skills.
• Excellent organization, multi-tasking skills
• Attentive to details, good initiative and able to work with changing priorities.

Nice To Haves

• 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level