Manage Canadian clinical trial start-up submissions using Health Canada knowledge and exact regulatory documentation from a remote position. Coordinate approvals and timelines for Premier Research projects.

As a Site Start-up Associate II, you support Premier Research’s Clinical Monitoring, Site Management and SSU team. You prepare Central and Local EC or IRB applications, regulatory authority submissions, and hospital approvals. You also review essential documents, informed consent materials, investigator contracts, and budgets. The work requires detailed knowledge of Canadian requirements, ICH/GCP guidelines, and clinical trial procedures.

Key Responsibilities:

- Forecast submission and approval timelines and manage adherence
- Prepare Central EC, IRB, Local EC, and regulatory submissions
- Resolve country-level EC, IRB,



and authority issues
- Collect and review essential documents for compliance
- Negotiate site-specific contracts and budgets when applicable

Requirements:

- Undergraduate degree in clinical, science, or health-related field
- Three or more years of direct study start-up experience
- Working knowledge of Health Canada submissions and clinical monitoring
- Knowledge of Canadian regulatory and site contract requirements
- Proficiency reviewing informed consent and patient documents

Apply regulatory expertise, submission coordination, and document review skills to Canadian clinical trial start-up at Premier Research.

📌 Canada Clinical Trial Start-Up Associate
🏢 Premier Research Group
📍 Canada