Clinical Research Quality Assurance Specialist

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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.

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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

• Participates in working groups (internal and external) to address organizational clinical research challenges.
• 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 by ensuring FH research teams and hospital support areas are prepared. Provides periodic reports on internal and external audit findings to thhe Manager, Clinical Trials and Business Development.
• Develops and implements a centralized review process for all applications and ongoing communications/submissions to regulatory authorities (e.g., Health Canada, FDA, etc.) for investigator¬ initiated regulated research. Verifies the accuracy and completeness of the applications prior to authorizing institutional signature. Develops, implements and maintains a tracking system for all pending, active and completed investigator-initiated applications to regulatory authorities.
• Leads in the investigation and resolution of actual or potential quality assurance or regulatory compliance issues associated with the conduct of clinical research at FH.
• 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 and maintains manuals, resources and templates related to the different regulatory application processes to Health Canada (i.e. drugs, biologics, medical devices, and natural health products).
• Develops content for the FH website (including the Clinical Research Resources and research quality sections). Provides consistent, timely communication to the FH research community regarding queries, quality assurance activities, new/revised procedures, and changes to the regulatory environment.
• Assists in the tracking of key performance metrics for FH. Provides periodic metrics reports as requested by the Manager, Clinical Trials and Business Development.
• 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.
• Acts as an expert resource to advise, guide and train the FH research community regarding methods to maintain high standards of quality and the mitigation of potential risks arising from the conduct of clinical research and related regulations, guidelines and best practices. Maintains a library of consults to ensure consistent, accurate information is delivered in the most efficient manner.
• 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.
• 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.

Qualifications

Bachelor's Degree (minimum) in a related discipline such as Science or Health Administration supplemented with a minimum of five (5) to seven (7) years of recent, related experience in clinical research, including coordinating or managing clinical trials. Experience coordinating multicenter and international trails preferred. Current Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals Certification (ACRP) preferred.

COMPETENCIES:

Demonstrates the leadership practices of the Fraser Health Leadership Framework of Clear, Caring and Courageous and creates the conditions for people to succeed.

Professional/Technical Capabilities

• Ability to use sound judgment and discretion, recognizing potential areas of sensitivity and handling appropriately.
• Ability to take a diplomatic and constructive approach to working with people and in a team environment.
• Attention to detail and highly developed organizational, prioritization and planning skills.
• Proficient knowledge of TCPS, GCP, FDA and Health Canada rules and regulations governing research.
• Ability to take direction as well as work independently.
• Possesses a high level of professional integrity.
• Proven knowledge of clinical research conduct.
• Ability to respond to multiple research support service requests/demands in a friendly, efficient, expert manner.
• Ability to implement a multi-faceted research quality initiative within a complex environment.
• Physical ability to perform the duties of the position.
• Critical assessment and objective evaluation skills.
• Strong electronic data management skills and advanced skills in Microsoft Office programs.
• Excellent written and verbal communication skills.