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. #J-18808-Ljbffr

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