Quality Assurance Specialist

The University of British Columbia (UBC) - Centre for Cardiovascular Innovation (CCI) is a clinical research operational center providing services to cardiovascular investigators working in British Columbia (B.C.) to facilitate national and international clinical trials.

CCI-CIC is dedicated to improving the health of patients with cardiovascular disease. CCI-CIC provides physical and personnel infrastructure to enhance the research capacity of its member investigators.

• CCI is a clinical research operations center that provides its member cardiovascular investigators with access to dedicated, expert personnel as well as organizational and physical infrastructure that will enhance their research scope and capacity.
• CCI is an inclusive center that offers membership to all cardiovascular investigators in BC (basic/clinical/allied health care) on mutually agreeable terms
• CCI provides a unified identity/affiliation for all Cardiovascular Investigators in BC
• CCI will establish transformative relationships with PHSA and Hospital Foundations

Maintaining and building the highest standards of quality and regulatory compliance in all facets of cardiovascular research makes the role of the Quality Assurance Specialist pivotal to CCI operations.

Moreover, the role entails maintaining and improving the efficacy of the Standard Operating Procedures (SOPs) or Quality Management System (QMS) in CCI, bringing it into compliance with Canadian and international standards while promoting ongoing quality improvements

• Quality Control: To ensure the correctness, dependability, and integrity of data, research methods, and reporting in the field of cardiovascular health, develop, implement, and maintain quality assurance procedures
• Data Integrity: Complete monitoring of data gathering, storage, and analysis processes to spot and correct errors or discrepancies. Check that the research techniques and data sources follow defined quality criteria.
• Regulatory Compliance: Keep abreast of pertinent laws and moral standards about research on cardiovascular health while ensuring that research activities and data management procedures meet all relevant regulatory requirements.
• Documentation: Keep an accurate and comprehensive record of all CCI quality assurance processes and procedures. Record quality control actions for later reference and establish audit trails.
• Internal Auditing: Ensure defined quality standards are followed and conduct routine internal audits of research projects, data-gathering techniques, and documentation. Work with external auditors as the need arises.
• Training and Education: Educate research personnel and partners on best practices for quality assurance. Encourage adherence to a culture of excellence throughout the company.
• Continuous Improvement: Review and enhance standards and procedures for quality assurance regularly. Determine what needs improvement, then work with the research team to implement those recommendations.

Organizational Status

The Quality Assurance Specialist is based within UBC. CCI collaborates with a comprehensive research network, promoting international and local research collaborations in cardiovascular health.

The Quality Assurance Specialist reports directly to the Director, Research Operations and is expected to work closely with other team members, including data analysts, statisticians, clinical coordinators, and researchers.

Work Performed
Technical-related

Uphold the effectiveness and accuracy of the Quality Management System (QMS) and ensure adherence to relevant national and international standards and laws. Oversee quality-related projects that spur systemic improvements while guaranteeing that they align with CCI's overall objectives. Work closely with cross-functional teams to identify nonconformities, gaps, and inefficiencies in CCI system procedures or processes. As needed, jumpstart the required corrective or preventive activities. Oversee the training and change control procedures in conjunction with the other CCI team members who handle quality assurance to guarantee complete adherence to all applicable laws and standards. Examine, review, and approve SOPs, validation/verification/stability documents, document change orders (DCO), document change requests, and document revisions. Offer CCI team members thorough training and professional direction on QMS procedures and processes. Examine risk management documents to support risk assessment and mitigation using a methodical, risk-based approach. Ensure that CCI is always audit-ready; actively participate in quality and regulatory audits. Actively participate in Management Review sessions and other projects by providing knowledge, experience, and the required backing for raising the standard of operations.

Develop quality-related metrics for internal monitoring within CCI; create related period reports for CCI top management. In charge of promptly resolving operational nonconformances (NCs), variations (VRs), reworks (RWs), and risk assessments, with a focus on careful root cause analysis at all times. Lead the cross-functional implementation of corrections and enhancements and continuously support and promote improvements in CCI's daily operations by identifying holes in the QMS. Ensure that all incoming, in-process, and finished materials/data/documents within CCI are accurately labeled and disposed of within the operations area. Supervise the distribution of QMS documents and effectively oversee the flow of records until they are completed as needed.

Management-related

Oversees a variety of duties associated with the position. Creates plans to improve work procedures continuously. Collaborates with users and stakeholders to gather needs; devises solutions for quality-related problems. Examines and suggests strategies and techniques to raise the standard of CCI operations.

Consequence of Error/Judgement

The role involves considerable initiative and attention to detail, with the incumbent managing multiple complex projects. Errors in judgment regarding project priorities, schedules, and resource requirements can result in project delays.

Effective communication is crucial, including clear and concise writing for documentation. The position requires working effectively under pressure to meet deadlines. Confidentiality is vital due to access to sensitive data.

Supervision Received

The Quality Assurance Specialist reports to the Director, Research Operations, with work reviewed regarding specific project objectives.

Supervision Given

No formal reports, but may supervise student staff.

Minimum Qualifications
Undergraduate degree in a relevant discipline. Minimum of two years of related experience, or an equivalent combination of education and experience.

- Willingness to respect diverse perspectives, including perspectives in conflict with one’s own

- Demonstrates a commitment to enhancing one’s own awareness, knowledge, and skills related to equity, diversity, and inclusion

Preferred Qualifications

• Postgraduate degree in a relevant discipline is an asset
• Internal audit certification or equivalent relevant certification (both Canadian and international, as applicable) is an asset
• Previous relevant experience in a healthcare, clinical research, or cardiovascular research setting
• Familiarity with working within a privacy-sensitive environment.
• Demonstrated expertise with ISO standards, related industry standards, legal requirements, and quality management systems.
• Strong attention to detail, preserving data quality, and ensuring research integrity
• Self-driven and capable of multitasking and working with minimum direction.
• Excellent teamwork skills and the ability to engage internal and external stakeholders.
• Outstanding writing and oral communication abilities combined with excellent attention to detail.
• Ability to effectively communicate with cross-functional teams to foster a cooperative work environment.
• Ability to oversee quality audits, create, evaluate, and maintain quality metrics, and lead ongoing improvement efforts.
• Excellent problem-solving abilities, with a focus on root cause analysis.
• Familiarity with the quality-management and database programs and Microsoft Office productivity suite
• A solid work ethic defined by a high standard of professional ethics and a constructive mindset focused on the team.