Clinical Research Quality Assurance Specialist

4 weeks ago

Toronto, Ontario, Canada Centre for Addiction and Mental Health Full time
Job Title: Quality Improvement Specialist

Centre for Addiction and Mental Health (CAMH) is seeking a Quality Improvement Specialist to join the Research Quality Assurance Office. This role is responsible for coordinating, facilitating, and evaluating activities aimed at establishing and maintaining quality assurance and regulatory compliance in the conduct of clinical research at CAMH.

Key Responsibilities:
  • Review and conduct risk assessments for new Clinical Trial Applications
  • Facilitate study activations, conduct study initiation visits, routine monitoring visits, and closeout visits
  • Conduct routine and directed audits and privacy reviews to verify compliance and quality assurance
  • Develop and implement a review process for research submitted for full research ethics review
  • Develop and maintain a comprehensive centralized review and approval process for CAMH investigator-initiated applications
  • Interface with research teams and establish institutional precedence to facilitate consistent decision-making
  • Communicate and promote the use of Institution-wide research policies and standard operating procedures
  • Develop and disseminate new policies and procedures in response to emergent issues impacting research quality and risk
Requirements:
  • Bachelor's degree in Life Sciences (graduate degree preferred)
  • Minimum of five years' experience in clinical research, including experience coordinating and managing clinical trials
  • Experience in monitoring, auditing, and inspection activities
  • Knowledge of Research Ethics Boards and Health Canada submissions
  • Knowledge of Clinical Trials Applications, Canadian Regulations, and clinical trial registration
Preferred Qualifications:
  • Post-graduate certificate and/or certification in clinical research
  • Experience coordinating multi-centre and international trials
  • Bilingualism (French/English) and/or proficiency in another language
What We Offer:
  • Competitive salary and benefits package
  • Opportunity to work with a leading research institution
  • Collaborative and dynamic work environment

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