Study Start-Up Coordinator– Remote
Core
Guide and administer internal study start-up processes and advise clients on Health Canada regulatory requirements for clinical trials.
Role type
Regulatory Submissions Coordinator (Clinical Operations)
Builds
Clinical trial applications and regulatory submissions for Health Canada
Domain
Clinical research / Regulatory affairs / Healthcare
Required skills
Health Canada submission expertise, Ethics submission expertise, ICH guidelines knowledge, regulatory compliance knowledge, document tracking, client advisory
Preferred skills
CRO experience, French language proficiency
Technologies
Health Canada submission systems, Ethics committee portals
Responsibilities
Act as the point of contact with sites during the study start-up process; Prepare, review, and file clinical trial applications to Health Canada; Ensure submissions comply with applicable regulations and guidance documents; Advise study teams on changing regulations and compliance requirements; Track and ensure timely filing of all essential start-up documents including Health Canada submissions.