Clinical Operations Specialist – Bilingual English/French

Responsibilities

• Preparing and coordinating regulatory submissions to Health Canada, Research Ethics Boards (REBs), and Institutional Review Boards (IRBs).
• Completing and maintaining Clinical Trial Site Information (CTSI) documentation.
• Managing regulatory documents and study files to ensure compliance and inspection readiness.
• Supporting multiple clinical studies simultaneously (typically 15+ active protocols).
• Processing clinical trial invoices accurately and efficiently.
• Tracking study documentation, regulatory milestones, and operational deliverables.
• Working cross‑functionally with clinical operations, regulatory, and study teams to ensure timely study execution.
• Maintaining accurate records within study systems and databases.
• Supporting study start‑up, maintenance, and closeout activities while ensuring adherence to sponsor processes and regulatory requirements.

Requirements

• Fluency in both English and French (written and spoken).
• Approximately 3+ years of clinical operations, clinical project associate, or equivalent clinical research experience.
• Strong working knowledge of Health Canada regulations.
• Extensive experience preparing and submitting regulatory packages to Health Canada.
• Experience with Research Ethics Board (REB) and/or Institutional Review Board (IRB) submissions.
• Hands‑on experience completing Clinical Trial Site Information (CTSI) forms.
• Experience processing clinical trial invoices.
• Ability to successfully manage 15 or more concurrent clinical protocols.
• Exceptional organizational skills with strong attention to detail.
• Ability to work independently in a fully remote environment while managing multiple priorities.