Clinical Trial Documentation Associate

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.