Quality Improvement Specialist - Research Operations, Services and Support-camh

The Research Quality Assurance Office is committed to providing oversight and supporting clinical research excellence by providing the research community at the Centre for Addiction and Mental Health (CAMH) with guidance, advice, and oversight of clinical trials and patient-based research, including regulatory support, education and training, and consultation services. The Research Quality Assurance Office is responsible for process improvement, monitoring oversight, the conduct of internal quality assurance audits, as well as assisting research team members during regulatory inspections.

CAMH is currently seeking a Quality Improvement Specialist for the Research Quality Assurance Office. Reporting to the Manager, Research Quality Assurance, the Research Quality Improvement Specialist is responsible and accountable for the coordination, facilitation, guidance and evaluation of activities aimed to establish and maintain quality assurance and regulatory compliance in the conduct of clinical research at CAMH.

In this role, you will review and conduct risk assessments for all new Clinical Trial Applications submitted by Investigators. You will facilitate study activations, conduct study initiation visits, routine monitoring visits and closeout visits as outlined within the monitoring plan for investigator-initiated and regulated research. You will conduct routine and directed audits and privacy reviews, using a risk-based formula to verify compliance and quality assurance. You will develop and implement a review process for all research submitted for full research ethics review to facilitate recognition of investigator-initiated and regulated research. You will develop and 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 facilitate regulatory compliance. You will facilitate regulatory inspections across the Institution by ensuring research teams and key support departments across the institution are audit-ready. You will assess current processes, develop methods and institute electronic systems to ensure quality and efficiency of processes. You will interface with research teams and establish institutional precedence to facilitate consistent decision-making, and communicate and promote the use of Institution-wide research policies and standard operating procedures for the conduct of clinical research. You will develop and disseminate new policies and procedures in response to emergent issues impacting research quality and risk. In addition, you will develop and maintain templates/resources to guide clinical research staff to facilitate regulatory compliance and identify ongoing education and support needs of the CAMH research community and collaborate on developing, delivering and evaluating education programs on a variety of clinical trial-related topics. This position is located at 1025 Queen Street West.

The successful candidate will have at minimum, a bachelor’s degree in Life Sciences (a graduate degree in Life Sciences or a related field is preferred), in addition to a minimum of five (5) years’ experience in clinical research which includes 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 and Health Canada submissions is required. Knowledge of Clinical Trials Applications, Canadian Regulations [Part C Division 5, Part 4 (Natural Health Products) and Part 3 (Medical Devices)], Controlled Drugs and Substance Act (CDSA), United States Code of Federal Regulations (CFR) and clinical trial registration required. A post-graduate certificate and/or certification (e.g. SOCRA) in clinical research is an asset.

You possess a proven ability to cultivate both internal and external relationships; motivate others; explain complex issues; possess excellent interpersonal, time management, and organizational skills. You demonstrate superior ability in planning, prioritizing, attention to detail and decision making. Your experience includes delivering presentations at local, national and international venues. You possess strong electronic data management skills and advanced skills in various applications including Microsoft Office, SharePoint and REDCap. You are self-directed, detail oriented and enjoy working as a member of a team. Excellent communication skills (both written and verbal), interpersonal skills, problem solving, decision making and organizational skills are essential. Bilingualism (French/English) and or proficiency in another language is an asset.

Please Note: This full-time, permanent position is NOT part of any bargaining union.

Salary Range: Competitive salary and benefits package.