Study Start-Up Coordinator

Accountabilities:

Serve as the primary point of contact for clinical research sites throughout the study start-up process, ensuring effective communication and coordination.
Prepare, review, and submit clinical trial applications and regulatory documentation to Health Canada.
Ensure that all regulatory submissions comply with applicable Canadian regulations, guidelines, and industry standards.
Advise internal study teams on evolving regulatory requirements, submission procedures, and compliance obligations.
Coordinate, track, and ensure the timely collection and filing of essential study start-up documentation.
Monitor submission progress and follow up with relevant stakeholders to support efficient study activation.
Collaborate with cross-functional clinical operations teams to maintain high-quality regulatory processes and meet study timelines.
Contribute to continuous process improvement while maintaining accuracy, consistency, and regulatory compliance across clinical research activities.
Requirements:
Bachelor's degree in a scientific, life sciences, or health-related discipline.
3 to 5 years of professional experience in the clinical research industry, with hands-on experience managing Health Canada and Research Ethics Board (REB) submissions.
Previous experience working within a Contract Research Organization (CRO) is strongly preferred.
Strong knowledge of Health Canada regulatory submission requirements, ICH-GCP guidelines, and applicable local clinical research regulations.
Experience preparing, reviewing, coordinating, and tracking regulatory documentation for clinical trials.
Excellent written and verbal communication skills, with the ability to interact effectively with clinical research sites and internal stakeholders.
Professional proficiency in English is required; French language skills are considered an asset.
Strong organizational skills and attention to detail, with the ability to manage multiple priorities and meet strict deadlines.
Ability to work independently in a remote environment while maintaining effective collaboration with a distributed team.
A proactive, positive, and self-motivated approach, combined with a strong commitment to quality, accuracy, and continuous improvement.
Benefits:
Competitive compensation: Attractive compensation programs that recognize and reward individual performance.
Comprehensive healthcare: Access to health and wellness benefits designed to support employees' overall well-being.
Retirement benefits: Retirement savings and benefits programs.
Paid time off: Generous paid time off (PTO) to support work-life balance.
Professional development: Structured onboarding and industry-recognized training programs to help accelerate career growth.
Continuous learning: Ongoing training opportunities and access to experienced mentors and clinical research experts.
Career advancement: Defined career paths and opportunities for professional progression within the clinical research industry.
Collaborative culture: Work alongside physicians, scientists, and experienced professionals in a supportive, multidisciplinary environment.
Meaningful work: Contribute to the development of innovative medical treatments and help improve patient outcomes worldwide.
Team engagement: Opportunities to participate in company-sponsored social activities and team-building initiatives.
Remote work: Full-time remote working arrangements for this position, offering flexibility and the opportunity to collaborate with an international team.