|Job Title: ||Clinical Research Quality Assurance Specialist|
|Work Site: ||2635 Laurel Street, 6th Floor|
Regular Full Time
As soon as possible
Days off: Saturday, Sunday, Statutory Holidays
Come work as a Clinical Research Quality Assurance Specialist with Vancouver Coastal Health (VCH)!
Vancouver Coastal Health is looking for a Clinical Research Quality Assurance Specialist to join the VCH Research Institute team. Apply today to join our team!
As a Clinical Research Quality Assurance Specialist with Vancouver Coastal Health you will:
- Work proactively with the management team at VCHRI to develop and implement strategies to support clinical research quality and regulatory compliance at VCH.
- Develop and lead information sessions/presentations for the VCH research community on research quality, regulatory compliance and best practices for the conduct of clinical research.
- Develop and implement 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.
- Develop and maintain manuals, resources and templates related to the different regulatory application processes to Health Canada (i.e. drugs, biologics, medical devices, and natural health products).
- Be 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 VCH and/or centrally coordinated by VCHRI researchers.
- Develop, implement and evaluate quality management systems for VCHRI (e.g., institutional vendor qualification, document management system, observation system etc.) Provide guidance and work with individual research teams to develop quality management systems suitable for implementation at the site-level.
- Develop, maintain and promote 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.
- Develop and implement strategies and tools for tracking deviations from SOPs research protocols or applicable regulations. Perform root cause assessments and makes recommendations for, or implements corrective and preventative actions (CAPA – Corrective and Preventative Actions).
- Facilitate clinical trial regulatory inspections/site audits across VCH by ensuring VCHRI research teams and hospital support areas are prepared. Provides periodic reports on internal and external audit findings to Director, Clinical Trials Administration.
- Lead in the investigation and resolution of actual or potential quality assurance or regulatory compliance issues associated with the conduct of clinical research at VCH.
- Act 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.
Education & Experience
- A level of education, training and experience equivalent to a 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’ 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.
Knowledge & Abilities
- Experience in a quality management capacity and/or SOP development is preferred.
- Experience with Research Ethics Boards and Health Canada is required.
- Experience in monitoring, auditing or inspection activities an asset.
- Proven knowledge of clinical research conduct.
- Demonstrated proficient knowledge of TCPS, GCP, FDA and Health Canada rules and regulations governing research.
- Demonstrated ability to implement a multi-faceted research quality initiative within a complex environment.
- Demonstrated ability to respond to multiple research support service requests/demands in a friendly, efficient, expert manner.
- Demonstrated ability to take a diplomatic and constructive approach to working with people and in a team environment.
- Possesses 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.
As per the current Public Health Orders (Long Term Care/Seniors Assisted Living Provincial Health Officer Order and the Health Sector Order), as of October 26, 2021, all employees working for Vancouver Coastal Health must be fully vaccinated for COVID-19. Proof of vaccination status will be required.
WHY JOIN VANCOUVER COASTAL HEALTH?
VCH is a world class innovator in medical care, research and teaching, delivering service to more than one million BC residents. At VCH, we embrace thinking boldly, taking smart risks, and "going first" when we believe it will lead to the best possible outcomes for patients and their families. We invite you to join us in creating healthy lives in healthy communities by showcasing our passion for care, connection to the communities we serve and our culture of teamwork that makes VCH a great place to work.
- Comprehensive health benefits package, including MSP, extended health and dental and municipal pension plan
- Grow your career with employer-paid training and leadership development opportunities
- Wellness supports, including counselling, critical incident and innovative wellness services are available to employees and their immediate families
- Award-winning recognition programs to honour staff, medical staff and volunteers
- Access to exclusive discount offers and deals for VCH staff
Diversity, equity, and inclusion are essential to our goals of creating a great place to work and delivering exceptional care. We acknowledge and accommodate unique differences and ensure special measures are in place so that all prospective and current employees are given an opportunity to succeed.
We are committed to building a representative workforce and encourage applications reflecting diversity of sex, sexual orientation, gender identity or expression, racialization or ancestry, disability, political belief, religion, marital or family status, age, and/or status as a First Nation, Metis, Inuit, or Indigenous person.
VCH is proud to be recognized as a Best Place to Work in Canada in 2021 by Glassdoor and Forbes.
Please note that a resume is required to apply to this posting.
Hours of Work may vary due to project requirements.
Only short-listed applicants will be contacted for this posting.
***Employees of VCH must apply via the Internal Application Process. Refer to the https://my.vch.ca/working-here/job-postings 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.