Quality Lead, Clinical Trials

Quality Lead, Clinical Trials

PHSA Corporate

Vancouver, BC

In accordance with the Purpose, Vision, Values and Coast Salish Teachings, and strategic directions of PHSA, safety, including both patient and employee safety, is a priority and a responsibility shared by everyone at PHSA. As such, the requirement to continuously improve quality and safety is inherent in all aspects of this position.

The Quality Lead, Clinical Trials is responsible for the development, management, and continuous improvement of an overall quality assurance program at the Provincial Health Services Authority. The position will be responsible for creating, implementing, and leading quality assurance processes, risk mitigation strategies, training, education, and support to the research community. The position will also facilitate external regulatory inspections, lead the implementation and maintenance of the Quality Management System, and other projects in support of research quality initiatives, coordinating clinical research professional practice activities, and facilitating the research integrity program.

What you’ll do

• Establishes and implements strategic Clinical Trial Assessment Program (CTAP) and corrective and preventive action (CAPA) system based on Health Canada regulations, International Conference on Harmonization (ICH) guidelines and/or Institutional Clinical Trial SOPs.
• Plans and monitors internal quality assessments of clinical research studies, processes, and programs, and performs quantitative & qualitative analysis of assessment findings and trends to ensure continuous process improvement.
• Leads the review of investigator-initiated protocols and prepares tools to strengthen investigator-initiated clinical trials.
• Acts as an expert resource to research investigators and staff on quality, regulatory and process issues. Participates in the development and evaluation of competencies for clinical research personnel. Prepares guidance documents, toolkits, and templates for clinical research staff. Identifies and makes appropriate changes to training and materials as required based on evaluations, client, partner, and peer feedback and observations.
• Acts as an expert resource and mentor to Quality Assurance personnel at PHSA and external Health Authorities.
• Acts as main contact and host of regulatory inspections of clinical trials. Leads preparation activities for regulatory inspections of clinical trials.
• Leads adoption and maintenance of the Quality Management System.
• Conducts evaluation, qualification, and surveillance of service providers for contracted clinical trial responsibilities.
• Represents the Institution in PHSA clinical trial quality initiatives.
• Develops reports including analysis/evaluation of findings, assigns grading criteria, and makes recommendations. Prepares and presents aggregate reports to Senior Management and research investigators to address systems level issues.
• Supervises, trains, and mentors Quality Assurance Associates and Clinical Trial Monitors.
• Responds on behalf of the Institution to Health Canada on regulatory and GCP consultations.
• Leads and develops feasibility analysis on potential satellite clinical trial sites to expand reach of clinical trials.

What you bring

Qualifications

• A level of education, training, and experience equivalent to equivalent to a Bachelor’s Degree in a scientific or health related field and five (5) years of experience in a research or regulatory environment. Current credentials/certification with a recognized Quality Assurance body (e.g., SQA, ASQ).
• Strong working knowledge of regulatory requirements, programs and issues related to the research environment. Thorough understanding of industry trends, standards, and methodologies. Sound knowledge of medical and scientific terminology. Excellent written and verbal communication skills. Strong organizational skills with outstanding attention to details. Demonstrated strong critical thinking skills. Excellent computer skills including MS Word, Excel and PowerPoint. Ability to manage complex and multiple projects. Work both independently and in a team environment. Demonstrated strong customer service orientation with excellent interpersonal skills. Mediation, conflict resolution, and negotiation skills.

Skills & Knowledge

• Awareness of and commitment to learning and understanding the Truth & Reconciliation Commission’s 94 Calls to Action (2015), In Plain Sight Report (2020), BC's Declaration on the Rights of Indigenous Peoples Act (2019), and Reclaiming Power and Place Missing and Murdered Indigenous Women & Girls calls for justice, and how they intersect across the health care system.
• Supports team members on their learning journey, ensuring education strategy for team/department to implement Indigenous Cultural Safety at a practical level.
• Works collaboratively with appropriate Indigenous teams/departments to ensure ICS lens applied holistically.
• Commitment to upholding the shared responsibility of creating lasting and meaningful reconciliation in Canada as per TRC (2015) and BC's Declaration on the Rights of Indigenous Peoples Act (2019).
• As a strong asset for consideration, we are looking for our successful candidate to have:  Knowledge of social, economic, political and historical realities impacting indigenous communities and familiarity with Indigenous Cultural Safety and anti-racism and accompanying reports (BC DRIPA, TRC, etc.).

What we bring

Every PHSA employee enables the best possible patient care for our patients and their families. Whether you are providing direct care, conducting research, or making it possible for others to do their work, you impact the lives of British Columbians today and in the future. That’s why we’re focused on your care too – offering health, wellness, development programs to support you – at work and at home.

• Join one of BC’s largest employers with province-wide programs, services and operations – offering vast opportunities for growth, development, and recognition programs that honour the commitment and contribution of all employees.
• Access to professional development opportunities through our in-house training programs, including +2,000 courses, such as our San’yas Indigenous Cultural Safety Training course, or Core Linx for Leadership roles.
• Enjoy a comprehensive benefits package, including municipal pension plan, and psychological health & safety programs and holistic wellness resources.
• Annual statutory holidays (13) with generous vacation entitlement and accruement.
• PHSA is a remote work friendly employer, welcoming flexible work options to support our people (eligibility may vary, depending on position).
• Access to WorkPerks, a premium discount program offering a wide range of local and national discounts on electronics, entertainment, dining, travel, wellness, apparel, and more.

Job Type: Regular, Full-Time

Salary Range: $86,398 - $124,197 /year. The starting salary for this position would be determined with consideration of the successful candidate’s relevant education and experience, and would be in alignment with the provincial compensation reference plan. Salary will be prorated accordingly for part time roles.
Location: 1333 W Broadway, Vancouver, BC V6H 1G9
Closing date: Applications accepted until position is filled
Hours of Work: 08:00-16:00 (Monday to Friday)
Requisition # 164084E

As per the current Public Health Order, full vaccination against COVID-19 is a condition of employment with PHSA as of October 26, 2021.

What we do

The Provincial Health Services Authority (PHSA) plans, manages and evaluates specialized health services with the BC health authorities to provide equitable and cost-effective health care for people throughout the province. Our values reflect our commitment to excellence and include: Respect people – Be compassionate – Dare to innovate – Cultivate partnerships – Serve with purpose.

Learn more about PHSA and our programs: jobs.phsa.ca/programs-and-services

PHSA is committed to employment equity, encouraging all qualified individuals to apply. We recognize that our ability to provide the best care for our diverse patient populations relies on a rich diversity of skills, knowledge, background and experience, and value a safe, inclusive and welcoming environment.

Reconciliation is an ongoing process and a shared responsibility for all of us. The BC Governments’ unanimous passage of the Declaration on the Rights of Indigenous Peoples Act was a significant step forward in this journey—one that all health authorities are expected to support as we work in cooperation with Indigenous Peoples to establish a clear and sustainable path to lasting reconciliation. True reconciliation will take time and ongoing commitment to work with Indigenous Peoples as they move toward self-determination. Guiding these efforts Crown agencies must remain focused on creating opportunities that implement the Truth and Reconciliation Commission Mandate.

ATTN: PHSA Employees:

To be considered as a PHSA employee (internal applicant) for this position, you must apply online via your internal profile at http://internaljobs.phsa.ca   

Please note the internal job posting will no longer be accessible after the expiry date of April 29, 2024. If the internal job posting has expired, please contact the Internal Jobs Help Desk and advise that you would like to be considered as a late internal applicant for this position. Please do not apply for the external job posting.

If you have not registered your internal profile, a password is required to log in for the first time. To obtain your password, please contact the Internal Jobs Help Desk at 604-875-7264 or 1-855-875-7264. Please note regular business hours are Monday – Friday (excluding stats), 8:30am to 4:30pm. For inquiries outside of regular business hours, please email the Internal Jobs Help Desk at internaljobshelpu@phsa.ca and a Help Desk Representative will contact you the next business day