An exciting permanent full-time opportunity as a Clinical Research and Quality Assurance Specialist (Competition #J0922-1925) exists in Research Operations, reporting to the Manager, Academic Operations & Solutions.
The Clinical Research and Quality Assurance Specialist is an integral team member of Women’s College Hospital Academics supporting initiatives to enhance and optimize the quality of research and clinical trials at the organization. Specifically, the Specialist is responsible for the coordination and conduct of the institutional review process for clinical trials, including Health Canada-regulated trials, as well as the facilitation of activities aimed at enhancing and maintaining quality assurance and regulatory compliance. The Specialist is a key resource to clinical research teams, supporting their work and providing guidance and advice. The incumbent must be willing to work collaboratively and cooperatively in a challenging and dynamic environment and will be responsible for the activities outlined below.
• *Summary of Duties, but not limited to**:
Support Clinical Research Quality Assurance and Regulatory Compliance
- Lead the WCH Clinical Trials activation process, including the intake, tracking, review of all clinical trials, and conduct of the Clinical Trial activation meetings
- Act as the primary liaison and support for WCH study teams planning Health Canada regulated clinical trials in navigating various institutional review and compliance requirements
- Assess the operational feasibility of all research studies planned at WCH using established institutional framework and make recommendations for project approval/execution
- Identify any issues or needs in the protocol (resources, privacy, data management, access, etc.) that may require the involvement of other internal or external stakeholders
- Develop risk mitigation plans and provide recommendations to senior leadership for decision making
- Engage with other departments within the hospital to exchange study information, plan study activities and negotiate courses of action on behalf of clinical research teams
- Work with clinical research teams to develop and implement a risk-based monitoring plan for WCH sponsored trials, consistent with relevant Health Canada regulations
- Liaise with investigators to ensure that all research studies are conducted in compliance with the approved protocol, Good Clinical Practice (GCP) and applicable regulatory requirements
- Work with the research operations field experts to ensure all project activities comply with applicable regulations, guidelines, and corporate policies
- Develop and/or participate in the development of project communications, training, regulatory submissions and/or audits and coordinate requests for regulatory audits
- Review all project specifications at beginning of each project and throughout the duration of the project and maintain complete regulatory documents and clinical study performance metrics for WCH sponsored trials
- Ensure and assist in the appropriate creation, delivery, maintenance and disposal of all related data, documents, equipment and tools, including protocols, SOPs, informed consent forms, case report forms and instructions.
Develop and deliver education and training
- Provide leadership to other clinical research staff by identifying internal and external educational opportunities, organizing community of practice meetings and delivering educational offerings driven by quality audit findings (e.g. forms and checklists, educational training, regulatory advice/consultation, etc.) for investigators and research staff
- Develop, coordinate, facilitate, and conduct and evaluate onboarding and orientation programs for new clinical research staff and other healthcare professionals involved in clinical research.
- Promote and educate clinical researchers regarding the regulations, guidelines and best practices for the conduct of clinical research
- Identify needs and deliver ongoing orientation, education and training to scientists, researchers and staff involved in clinical trials and research on appropriate clinical research conduct, laws, regulations, and standards, and compliance with applicable SOPs and policies.
- Collaborate and communicate with other TAHSN quality assurance offices to share best practices and opportunities
Support quality assurance for all research projects at WCH
- Lead/participate in research quality initiatives, including development of systems and processes to support risk management, responsible conduct of research and research integrity
- Serve as WCH primary contact for all research quality assurance activities and as the control point for communication and problem solving for sponsors, research organizations and other WCH departments as required.
- Identify gaps in workflows and work closely with research teams and institutional service providers to identify methods and tools to facilitate improvement
- Monitor quality as
