As a Study Start-Up Coordinator, you will play a key role in facilitating the regulatory and administrative processes required to launch clinical research studies successfully. You will oversee regulatory submissions, coordinate with clinical research sites, and ensure that all essential documentation meets Health Canada requirements. Working across diverse clinical trials, therapeutic areas, and study phases, you will collaborate with internal teams and external stakeholders to maintain regulatory compliance and operational efficiency.

You will also provide guidance on evolving regulatory requirements and help ensure that study start-up activities are completed accurately and on schedule. This remote opportunity offers exposure to international clinical research projects within a collaborative, quality-driven environment. Your expertise will contribute directly to advancing clinical development and bringing innovative medical treatments closer to patients worldwide.

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. 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. Bachelor's degree in a scientific, life sciences, or health-related discipline. ~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. ~ Ability to work independently in a remote setting 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. Attractive compensation programs that recognize and reward individual performance.

Retirement benefits: Retirement savings and benefits programs. Structured onboarding and industry-recognized training programs to help accelerate career growth. Ongoing training opportunities and access to experienced mentors and clinical research experts. Contribute to the development of innovative medical treatments and help improve patient outcomes worldwide. 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.

📌 Study Start-Up Coordinator (Mississauga)
🏢 Jobgether
📍 Mississauga