Clinical Research Quality Assurance & Process Implementation Specialist
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.
- Develops and implements 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.
- Plans and conducts internal quality audits of clinical research studies, processes, and programs, and performs quantitative & qualitative analysis of audit findings and trends to ensure continuous process improvement.
- Creates and implements 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.
- Acts as an expert resource to research investigators and staff on quality, regulatory and process issues. Supports 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.
- 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, stakeholder and peer feedback and observations.
- 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.
- Leads data generation and gathering processes in support of quality initiatives by liaising with BCCH and BCW investigators. Coordinates with Clinical Trials Managers to obtain data, as necessary.
- Collects and maintains Curriculum Vitae (CV) for research staff to ensure current licensing, certifications, adequate training, and related credentials conform to clinical research study criteria.
Education, Experience and Training:
- A level of education, training, and experience equivalent to a Bachelor’s Degree in a Scientific or Health related field.
- 3 years of experience in a research or regulatory environment.
Skills and Abilities:
- 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.
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