Manage Canadian clinical trial start-up submissions using Health Canada knowledge and precise 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 in Ottawa employer: Premier Research Group
At Premier Research, we pride ourselves on being an exceptional employer that values innovation and collaboration in the healthcare sector. Our remote work culture fosters flexibility and inclusivity, allowing you to thrive while making a meaningful impact in dermatology. With ample opportunities for professional growth and a commitment to employee well-being, you'll find a rewarding career path that aligns with your passion for transforming patient care.
