BCCHR: Clinical Research Quality Assurance & Process Implementation Specialist

Closed
Open until filled
Yes
Internal / External
External to BC AHSN
Job type
Full time
Location
Vancouver Coastal Health Region
How to apply

Please apply directly to PHSA job portal: 

Apply here

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Job Type: Regular, Full-Time

Location: 4500 Oak Street, Vancouver, V6H 2N9

Applications will be accepted until position is filled.

Hours of Work: Monday to Friday; 0800-1600/0830-1630/0900-1700

Requisition # 120524

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

The Clinical Research Quality Assurance and Process Implementation Specialist is responsible for the development, management, and continuous improvement of an overall quality assurance program at the BC Children’s Hospital (BCCH) and BC Women’s Hospital & Health Centre (BCW). The position is responsible for creating and implementing quality assurance processes, risk mitigation strategies, training, education, and support to the research community as part of a PHSA-wide clinical research quality assurance program. The position also facilitates external regulatory audits, lead projects in support of research quality initiatives, coordinates clinical research professional practice activities, and facilitates the research integrity program.


What you’ll do:

  • Develop and implement a PHSA clinical research quality management program for BC Children’s Hospital and BC Women’s Hospital & Health Centre, in collaboration with PHSA Research Services and other PHSA clinical research quality staff.
  • Plan and conduct internal quality audits of clinical research studies, processes, and programs, and perform quantitative & qualitative analysis of audit findings and trends to ensure continuous process improvement.
  • Create and implement strategic audit program and corrective and preventive action (CAPA) plan based on Health Canada regulations, International Conference on Harmonization (ICH) guidelines and/or BCCH/BCW SOPs.
  • Act as an expert resource to research investigators and staff on quality, regulatory and process issues. Support the profession growth and development of clinical research staff by training and mentoring as well as increasing overall awareness with regards to the use of program specific tools, processes and practices to improve the overall conduct and quality of clinical research.
  • Participate in the development and evaluation of competencies for clinical research personnel. Prepare guidance documents, toolkits and templates for clinical research staff. Identify and make appropriate changes to training and materials as required based on evaluations, client, stakeholder and peer feedback and observations.
  • Develop reports including analysis/evaluation of findings, assign grading criteria, and make recommendations. Prepare and present aggregate reports to Senior Management and research investigators to address systems level issues.

What you bring:

  • A level of education, training, and experience equivalent to a Bachelor’s Degree in a Scientific or Health related field and three (3) years of experience in a research or regulatory environment.

You will also have:

  • Working knowledge of regulatory requirements, programs and issues related to the research environment. Thorough understanding of industry trends, standards, and methodologies.
  • Knowledge of medical and scientific terminology.
  • Excellent written and verbal communication skills.
  • Strong organizational skills with outstanding attention to details.
  • Demonstrated 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

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 and development.
  • 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).
  • Perks include access to fitness classes and discounts to 350 BC-wide recreational programs, travel, technology, car and bike sharing, and more.

What we do:

BC Children’s Hospital (BCCH) provides care for the most seriously ill or injured children and youth from across British Columbia.

BCCH is part of the Provincial Health Services Authority (PHSA).

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.

PHSA and BCCH are 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.