Research Quality Improvement Specialist Research Operations, Services and Support

Through its core values ofCourage Respect and Excellence CAMH is implementing its Strategic Plan:Connected CAMHto transform lives ignite innovation and discovery revolutionize education and drive social change. CAMH is more than a hospital it is a cause. CAMH is on a mission to change the way society thinks about and responds to mental illness. They aim to eliminate prejudice and discrimination and shape a world where mental illness is central to our healthcare system a world where Mental HealthisHealth.

To learn more about CAMH please visit their website at:.

To view our Land Acknowledgment please clickhere.

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. Research Quality Assurance Office is responsible for process improvement monitoring oversight the conduct of internal random and directed quality assurance audits as well as assisting research team members during regulatory inspections.

CAMH is currently seeking a full-time permanent Research Quality Improvement Specialist for the Research Quality Assurance Office. Reporting to the Manager Research Quality Assurance for daily operations 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 assist and mentor monitors with routine monitoring visits and closeout visits as outlined within the monitoring plan for investigator-initiated and regulated research to ensure oversight of the trial. 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 REB 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 institution and support departments are prepared. You will assess current processes and institute electronic systems and develop methods 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 addition you will develop and maintain templates and resource to guide clinical research staff in the conduct of clinical research 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.

The successful candidate will have at minimum a bachelors 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. Certificates demonstrating competency in Tri-Council Policy Statement (TCPS2): Ethical Conduct for Research Involving Humans and International Conference on Harmonization Good Clinical Practice (ICH-GCP) Responsible Conduct of Research (RCR) are 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 (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.