Quality Lead, Clinical Trials
2 months ago
**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.
- Co
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