Regulatory Research Coordinator

1 week ago

Brampton, Ontario, Canada William Osler Health System Full time
Job Summary

We are seeking a highly skilled Regulatory Research Coordinator to join our team at William Osler Health System. As a key member of our Research team, you will be responsible for ensuring the regulatory compliance of our research protocols and ensuring the quality of our research operations.

Key Responsibilities
  • Regulatory Oversight: Manage all aspects of regulatory oversight for trials, from start-up through study closeout, and protocols in development.
  • Documentation Management: Prepare and review research ethics board (REB) applications and submissions, amendments, and annual renewals.
  • Consent Document Development: Develop, review, and edit informed consent documents, ensuring compliance with local and sponsor regulations.
  • Reporting and Compliance: Report pertinent safety data and deviation notifications to the REB and prepare, review, and submit safety reports quarterly or annually.
  • Regulatory Binder Maintenance: Maintain study trial delegation of responsibility logs and keep record of all training documentation for site staff.
  • Facilitation and Coordination: Facilitate internal and external monitoring and auditing of regulatory files by the sponsor, contract research organization, or other entity.
  • Quality Assurance: Review and adapt existing standard operating procedures, templates, databases, and organizational systems as developed for the management of regulatory and quality assurance activities.
Qualifications
  • Education: Undergraduate certificate or Bachelor's degree in health science or related field.
  • Experience: Experienced research professional (SOCRA Certification required) with a minimum of two years working experience as a regulatory coordinator.
  • Skills: Strong working knowledge of Canadian, American, and international regulatory guidelines, expert knowledge of Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, Health Canada's Part C Division 5 of the Food and Drug Regulations, and FDA regulations.
  • Additional Requirements: Flexible and cooperative spirit with a strong commitment to team efforts, proven ability to prioritize workload and meet deadlines, outcome-drive self-starter with the ability to work independently, excellent organizational, prioritization, and time-management skills.

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