Clinical Start-Up Specialist II — Impact & Growth

Premier Research Group; Canada; On-site; CAD 65,000 - 90,000; Full time

Job summary

Premier Research Group is seeking a Site Start up Associate II to join our Clinical Monitoring, Site Management and SSU team in Canada. You will support biotech, medtech, and pharma projects, helping transform ideas into medicines and diagnostics while upholding our commitment to patient safety and data integrity.

You will coordinate regulatory submissions, manage essential documents, and negotiate site contracts.

Qualifications

• 3+ years direct study start up experience.
• Knowledge of Health Canada submissions, FDA guidance, EU directives and ICH/GCP.
• Ability to work independently and meet deadlines with minimal supervision.

Responsibilities

• Forecast submission timelines, provide rationale for delays, and escalate as needed.
• Prepare and submit EC/IRB, Local EC, RA applications, and hospital approvals.
• Review essential documents to ensure sponsor and investigator compliance.
• Negotiate site contracts and budgets with sites and Contracts Lead until resolution.
• Review informed consent templates and country-specific patient documents.

Skills

Startup experience

Regulatory submissions knowledge

Independent work ability

Education

Undergraduate degree in clinical/science/health field

Job description

Premier Research Group is seeking a Site Start up Associate II to join our Clinical Monitoring, Site Management and SSU team in Canada. You will support biotech, medtech, and pharma projects, helping transform ideas into medicines and diagnostics while upholding our commitment to patient safety and data integrity.

You will coordinate regulatory submissions, manage essential documents, and negotiate site contracts.