Drive regulatory affairs for Canadian clinical trials through submission planning, document review, and approval coordination. Work remotely with Premier Research’s clinical start-up team.
This Site Start-up Associate II position supports biotech, medtech, and specialty pharma studies through country-level start-up activities. You prepare EC, IRB, regulatory authority, and hospital approval applications while addressing submission issues. You review essential documents and informed consent materials, and may negotiate investigator contracts and budgets. Success requires independent, accurate work within agreed timelines.
Key Responsibilities: Coordinate forecasts for submission and approval milestones
Submit local regulatory and institutional approval applications
Provide rationale and contingency plans for identified delays




Review sponsor and investigator essential documents
Adapt informed consent and patient document templates
Requirements: Three or more years of direct study start-up experience
Degree in clinical, science, or health-related discipline
Detailed knowledge of country-specific clinical trial requirements
Working knowledge of Health Canada and applicable regulations
Ability to work independently with minimal supervision
Bring Canadian regulatory affairs experience, submission expertise, and careful document review to Premier Research study start-up projects.

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📌 Regulatory Affairs Site Start-Up Associate (Ontario)
🏢 Premier Research Group
📍 Ontario