Research Quality Improvement Specialist Research Operations, Services and Support

Job Description Through its core values of Courage, Respect and Excellence CAMH is implementing its Strategic Plan: Connected CAMH to transform lives, ignite innovation and discovery, revolutionize education and drive social change. CAMH is more than a hospital; it is a cause. CAMH’s mission is to change the way society thinks about and responds to mental illness, aiming to eliminate prejudice and discrimination and shape a world where mental illness is central to our healthcare system, a world where Mental Health is Health. Research Quality Assurance Office is committed to providing oversight and supporting clinical research excellence by guiding, advising and overseeing clinical trials and patient-based research at the Centre for Addiction and Mental Health (CAMH). The Office is responsible for process improvement, monitoring, oversight of internal audits, and assistance to research team members during regulatory inspections. Responsibilities Review and conduct risk assessments for all new Clinical Trial Applications submitted by investigators. Facilitate study activations, conduct study initiation visits, and assist/mentor monitors during routine monitoring and closeout visits based on the monitoring plan for investigator-initiated and regulated research. Conduct routine and directed audits and privacy reviews using a risk-based formula to verify compliance and quality assurance. Develop and implement a review process for all research submitted for full REB review to facilitate recognition of investigator-initiated and regulated research. Maintain a comprehensive centralized review and approval process for all CAMH investigator-initiated applications and ongoing communications/submissions to Health Canada to ensure accuracy and regulatory compliance. Facilitate regulatory inspections across the institution by ensuring research teams and key departmental partners are prepared. Assess current processes, institute electronic systems, and develop methods to ensure quality and efficiency. Interface with research teams and establish institutional precedence for consistent decision‑making; promote the use of institution-wide research policies and standard operating procedures for the conduct of clinical research. Develop, disseminate, and maintain new policies and procedures in response to emerging issues impacting research quality. Create templates and resources to guide clinical research staff on regulatory compliance and identify ongoing education and support needs of the CAMH research community. Collaborate on developing, delivering, and evaluating education programs on a variety of clinical trial‑related topics. Minimum Requirements Bachelor’s degree in Life Sciences (a graduate degree in Life Sciences or a related field is preferred). Minimum of five (5) years of experience in clinical research, including demonstrated experience coordinating and managing clinical trials. Experience in monitoring, auditing and inspection activities is required. Experience coordinating multi‑centre and international trials is preferred. Experience with and knowledge of Research Ethics Boards (REB) and Health Canada submissions is required. Knowledge of Canadian regulations (Part C, Division 5 and Part 4 for Natural Health Products; Part 3 for Medical Devices; Controlled Drugs and Substance Act) and United States Code of Federal Regulations (CFR) and clinical trial registration is required. Certificates demonstrating competency in Tri‑Council Policy Statement (TCPS2), International Conference on Harmonization Good Clinical Practice (ICH‑GCP), and Responsible Conduct of Research (RCR) are required. A post‑graduate certificate and/or certification (e.g., SOCRA) in clinical research is an asset. Other Qualifications and Skills Proven ability to cultivate internal and external relationships, motivate others, explain complex issues, and exhibit excellent interpersonal, time‑management, and organizational skills. Superior planning, prioritizing, attention to detail, and decision‑making abilities. Experience delivering presentations at local, national, and international venues. Strong electronic data management skills and advanced proficiency in Microsoft Office, SharePoint, and REDCap. Self‑directed, detail‑oriented, and collaborative team player. Excellent written and verbal communication skills; proficiency in French or English is required; proficiency in another language is an asset. Job Details This full‑time permanent position is not part of any bargaining union. Salary: Competitive salary and benefits package. Employment type: Full Time. Vacancy: 1. #J-18808-Ljbffr