Study Start-Up Coordinator
Core
Facilitate regulatory and administrative processes to launch clinical research studies, ensuring compliance with Health Canada requirements.
Role type
Study Start-Up Coordinator
Builds
Clinical research studies
Domain
Clinical research / Life sciences
Required skills
Health Canada regulatory submissions, ICH-GCP guidelines, clinical trial documentation management, regulatory compliance, stakeholder coordination, study start-up tracking
Preferred skills
CRO experience, French language skills
Technologies
Health Canada submission systems, REB portals
Responsibilities
Serve as primary point of contact for clinical research sites; Prepare, review, and submit clinical trial applications to Health Canada; Ensure regulatory submissions comply with Canadian regulations; Advise internal teams on evolving regulatory requirements; Coordinate and track study start-up documentation; Monitor submission progress and follow up with stakeholders; Collaborate with cross-functional teams to meet study timelines
Seniority
Mid-level, hands-on IC