|Job Title: ||Clinical Research Quality Assurance Specialist|
|Work Site: ||VGH 12th & Oak|
|Status: ||Regular Full Time - Baseline (1.00 FTE)|
About Vancouver Coastal Health Research Institute (VCHRI)
The Vancouver Coastal Health Research Institute (VCHRI) is committed to supporting clinical research excellence by providing its research community with guidance, advice, and oversight of clinical trials and patient-based research.
Learn more about us at www.vchri.ca
Reporting to the Director, Clinical Trials Administration and the Manager of the Clinical Research Unit, you will be 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 Vancouver Coastal Health (VCH).
Emphasis is placed on providing support and oversight to VCHRI researchers conducting investigator-initiated and regulated research. The Specialist is expected to independently liaise with the VCHRI research community (including physicians, investigators, researchers, research coordinators, and research assistants conducting research at VCH), the research ethics board, VCH departments linked to research, clinical trial sponsors, regulatory bodies, and other external groups and research networks.
Duties will include, but not be limited to:
- Working proactively with the management team to develop and implement strategies to support clinical research quality and regulatory compliance.
- Developing and leading information sessions/presentations for the VCH research community on research quality, regulatory compliance and best practices for the conduct of clinical research.
- Developing and implementing 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.
- Verifying accuracy and completeness of applications prior to authorizing institutional signature and developing, implementing and maintaining a tracking system for all investigator-initiated applications to regulatory authorities.
- Developing and maintaining manuals, resources and templates related to the different regulatory application processes to Health Canada (i.e. drugs, biologics, medical devices, and natural health products).
- Assuming responsibility 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 VCH and/or centrally coordinated by VCHRI 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, which will include evaluating the program and revising processes as appropriate.
- Developing, implementing and evaluating quality management systems, providing guidance and working with individual research teams to develop quality management systems suitable for implementation at the site-level.
- Developing, maintaining and promoting the use of institution-level clinical research standard operating procedures (SOPs) and associated forms and templates, developed in compliance with VCHRI departmental requirements, and applicable provincial and international regulations (Canada and US); Providing ongoing support to VCH researchers to foster compliance with institution-level clinical research SOPs and to assist with development of program/site-level SOPs and coordinating and completing revisions of institution-level clinical research SOPs based on changes in the regulatory environment.
- Developing and implementing strategies and tools for tracking deviations from SOPs research protocols or applicable regulations, performing root cause assessments and making recommendations for, or implementing corrective and preventative actions.
- Facilitating clinical trial regulatory inspections/site audits across VCH. ensuring VCHRI research teams and support areas are prepared and providing periodic reports on audit findings to Director, Clinical Trials Administration.
- Leading in the investigation and resolution of actual or potential quality assurance or regulatory compliance issues associated with the conduct of clinical research at VCH.
- Acting as an expert resource to advise, guide and train the VCH 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. Maintaining a library of consults to ensure consistent, accurate information is delivered in the most efficient manner.
- Developing content for the VCHRI website (including the Clinical Research Resources and research quality sections).
- Assisting with tracking key performance metrics and providing periodic metrics reports to the Director, Clinical Trials Administration.
- A level of education, training and experience equivalent to a Bachelor’s Degree in a related discipline such as Science or Health Administration supplemented with a minimum of five (5) to seven (7) years’ recent, related experience in clinical research, including coordinating or managing clinical trials.
- Experience coordinating multicenter and international trials preferred.
- Current Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals Certificate (ACRP) preferred.
Role Specific Expertise:
- Experience with Research Ethics Boards and Health Canada is required.
- Experience in a quality management capacity and/or SOP development is preferred.
- Experience in monitoring, auditing or inspection activities an asset.
- Proven knowledge of clinical research conduct.
- Demonstrable proficiency knowledge of TCPS, GCP, FDA and Health Canada rules and regulations governing research.
- Demonstrable ability to implement a multi-faceted research quality initiative within a complex environment.
- Demonstrable ability to respond to multiple research support service requests/demands in a friendly, efficient, expert manner.
- Demonstrable ability to take a diplomatic and constructive approach to working with people and in a team environment coupled with
- A high level of professional integrity.
- Demonstrated excellent written and verbal communication skills.
- Demonstrated ability to use sound judgment and discretion, recognizing potential areas of sensitivity and handling appropriately.
- Critical assessment and objective evaluation skills.
- Attention to detail and highly developed organizational, prioritization and planning skills.
- Ability to take direction as well as work independently.
- Strong electronic data management skills and advanced skills in Microsoft Office programs.
- Physical ability to perform the duties of the position.
VCH Management Competencies:
You question actions inconsistent with our values
You treat people with fairness and respect independent of their status or disagreement with you
You hire great people and expect great things from them
You inspire others with your thirst for excellence
You create an environment where people can flourish and grow
You seek what is best for the health system, rather than the best for yourself or your group.
Courage to Innovate
You challenge the status quo to improve quality and sustainability
You take smart risks and make tough decisions without agonizing
Qualified applicants only please submit a resume and covering letter quoting competition # 103450-tbo .
- Only short-listed applicants will be contacted for this posting.
- Successful applicants may be required to complete a Criminal Records Review Check.
***Employees of VCH must apply via the Internal Application Process. Refer to the staffpostings.vch.ca site for How to Apply instructions. Current VCH employees who apply to this posting using this external site will be considered as an external candidate. Seniority will not apply.***
Thank you for your interest in Vancouver Coastal Health.