Clinical Operations Specialist – Bilingual English/French
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Job Description
Clinical Operations Specialist supporting multiple clinical studies across Canada in a fast-paced remote environment. Focused on regulatory submissions and compliance management for clinical trials across Health Canada.
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.
Benefits:
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to building an inclusive culture – where you can authentically be yourself.
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