Clinical Research Quality Assurance Specialist
2 weeks ago
Why Fraser Health?:
Fraser Health continues to be recognized as one of BC's Top Employers, are you someone who is passionate about making a difference in the lives of others?
Fraser Health is responsible for the delivery of hospital and community-based health services to over 1.9 million people in 20 diverse communities from Burnaby to Fraser Canyon on the traditional territories of the Coast Salish and Nlaka’pamux Nations. Our team of nearly 45,000 medical staff and volunteers is dedicated to serving our patients, families and communities to deliver on our vision: Better health, best in health care.
Effective October 26th, 2021, all new hires to Fraser Health will need to have full COVID 19 vaccination (have received a full series of a World Health Organization “WHO” approved vaccine against infection by SARS-COV-2, or a combination of approved WHO vaccines). Please note this applies to all postings, and individual medical exemptions must be approved by the Provincial Health Officer.
Come work with dedicated health care providers who are enthusiastic and committed to provide quality healthcare to our clients/patients/residents. We invite you to find out why more than 95% of new employees recommend Fraser Health as an excellent place to work. Work hard and have fun while you do it.
Curious to learn what it’s like to work here? Like us on
**LinkedIn** (fraserhealthcareers) for first-hand employee insights.
Detailed Overview:
**Supporting the Vision, Values, Purpose and Commitments of Fraser Health including service delivery that is centered around patients/clients/residents and families**:
Fraser Health is committed to supporting clinical research excellence by providing its research community with guidance, advice, and oversight of clinical trials and patient-based research.
Reporting to the Manager, Clinical Trials and Business Development, the Clinical Research Quality Assurance Specialist is responsible and accountable for the development, coordination, facilitation, guidance and evaluation of activities aimed at raising the standard of clinical research and therefore human research participant protection, through education process improvements, internal quality assurance and regulatory compliance at Fraser Health (FH). Emphasis is placed on providing support and oversight to FH researchers conducting investigator-initiated and regulated research. The Specialist is expected to independently liaise with the FH research community (including physicians, investigators, researchers, research coordinators, and research assistants conducting research at FH), the research ethics board, FH departments linked to research, clinical trial sponsors, regulatory bodies, and other external groups and research networks.
**Responsibilities**:
- Works proactively with the research management team at FH to develop and implement strategies to support clinical research quality and regulatory compliance at FH.
- Develops and leads information sessions/presentations for the FH research community on research quality, regulatory compliance and best practices for the conduct of clinical research.
- Responsible for the overall conduct and implementation of an institution-wide review and approval process (mandatory) for all investigator-initiated and regulated research (i.e. requires Health Canada Approval) and that is conducted at FH and/or centrally coordinated by FH researchers. Maintains an internal tracking system for all assessments that are conducted. Documents (via metrics, templates, reports, etc.) and reports to the management team on quality assurance and compliance findings resulting from the assessments. Evaluates the program and revises processes as appropriate.
- Develops, implements and evaluates quality management systems (QMS) for FH (e.g., institutional vendor qualification, document management system, observation system etc.) Provides guidance and works with individual research teams to develop quality management systems suitable for implementation at the site¬ level.
- Develops, maintains and promotes the use of institution-level clinical research standard operating procedures (SOPs) and associated forms and templates, developed in compliance with FH departmental requirements, and applicable provincial and international regulations (Canada and US). Provides ongoing support to FH researchers to foster compliance with institution-level clinical research SOPs and to assist with development of program/site-level SOPs. Coordinates and completes revisions of institution-level clinical research SOPs based on changes in the regulatory environment.
- Develops and implements strategies and tools for tracking deviations from SOPs research protocols or applicable regulations. Performs root cause assessments and makes recommendations for, or implements corrective and preventative actions (CAPA - Corrective and Preventative Actions).
- Facilitates clinical trial regulatory inspections/site audits across FH b
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