Quality Assurance Lead at The Maternal Infant Child and Youth Research Network (MICYRN)

Position Summary

The Maternal Infant Child and Youth Research Network (MICYRN) is a federal not-for-profit, charitable organization founded in 2006 to build capacity for high-quality applied health research. It currently links 21 maternal and child health research organizations based at academic health centres in Canada and is affiliated with more than 25 practice-based research networks of investigators from across teaching hospitals which are affiliated with the 17 medical schools in Canada. MICYRN’s principal role is to improve the quality and impact of research through the provision of a coordinated infrastructure to support research teams working across Canada and beyond. In support of the clinician-scientists and clinician-investigators in the maternal, perinatal, and child health research space, MICYRN has acquired the expertise to function as a de-centralized Academic Research Organization (ARO).

Embedded withing MICYRN, RareKids-CAN: Pediatric Rare Disease Clinical Trials and Treatment Network is a platform dedicated to building an infrastructure to advance clinical trials and access to treatment for children with rare diseases in Canada.  The Network is grant funded by the Canadian Institutes of Health Research (CIHR) for 5 years with the intention to build a cost-recovery and self-sustaining network beyond the grant funding.  RareKids-CAN is a coalition of diverse national and international experts, researchers, industry partners, research networks, patient-partners and patient partner organizations pooling their collective knowledge and experience in the pediatric rare disease community.

MICYRN is seeking a full-time Quality Assurance (QA) Lead to support compliance and QA practices within the organization and amongst its membership (where applicable). The ideal candidate will be responsible for ensuring that clinical research facilitated or sponsored by MICYRN or a MICYRN member organization adhere to regulatory requirements, high quality standards, and all relevant policies and procedures. This role will oversee QA for the MICYRN organization and its members with a primary focus on developing quality assurance strategies, providing guidance to the organization and external project teams, and ensuring audit/inspection readiness throughout the clinical trial lifecycle. The scope of this role includes both academic and industry sponsored clinical trials and research. The Quality Assurance Lead will report to the Network Director, RareKids-CAN.

The successful applicant must reside within Canada (Canadian Citizen or Permanent Resident) and be available to travel nationally to support QA or organizational needs. MICYRN is committed to an equitable, diverse, and inclusive workforce. We welcome applications from all qualified persons. We encourage women; First Nations, Métis and Inuit persons; members of visible minority groups; persons with disabilities; persons of any sexual orientation or gender identity and expression; and all those who may contribute to the further diversification of ideas and organization to apply.

Responsibilities

• Oversee, develop, and maintain quality assurance plans and procedures for clinical research, including risk assessment and mitigation strategies.
• Collaborate with cross-functional teams to identify areas for process improvement and implement corrective and preventive actions as needed.
• Provide guidance on quality assurance matters, including interpretation of regulations, standards, and guidelines.
• Prepare and assist MICYRN and MICYRN member organizations for regulatory audits/inspections by Health Canada (or other regulatory bodies).
• Perform risk-based sponsor audits of clinical trial activities, Trial Master Files (TMF), and documents, to ensure compliance with regulatory requirements and MICYRN policies and procedures as applicable.
• Ensure that MICYRN Policies, and Standard Operating Procedures (SOPs) are reviewed periodically and complete necessary additions, and revisions to ensure compliance with ethical, regulatory, and other relevant frameworks.
• Support MICYRN member organizations in the development and review of local policies and SOPs as needed to ensure compliance and adherence with ethical, regulatory, and other relevant frameworks.
• Participate in working groups, QA initiatives and educational opportunities to stay current on Health Canada inspection trends, best practices, and regulatory requirements related to clinical research quality assurance.
• Coordinate with the MICYRN Clinical Trials Monitoring Lead to develop and provide clinical research education and training sessions to MICYRN personnel and affiliated MICYRN member organizations.

Qualifications

• Undergraduate degree, preferably in a health-related discipline (Essential)
• Completion of additional clinical research education and certification (eg. ACRP, SOCRA) (Essential)
• Minimum of 3 years of experience in clinical research quality assurance or monitoring within the pharmaceutical, biotechnology, or medical device industry (Essential)
• Previous experience conducting audits of clinical trial activities, including site/sponsor audits and regulatory inspections (Essential)
• Demonstrated knowledge of laws, standards, and regulations related to obtaining regulatory approvals from Health Canada (Essential)
• In-depth knowledge of clinical trial methods, conduct, and execution (Essential)
• Experience mentoring and supervising quality assurance and monitoring personnel (Asset)
• Familiarity with challenges pertaining to mothers and children in clinical research (Asset)
• Experience with clinical research databases (electronic data capture systems and clinical trial management systems) (Essential)
• Intermediate proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook) and videoconference tools (Zoom, Microsoft Teams) (Essential)
• Demonstrated productivity and self-motivation in remote/hybrid work environments (Essential)
• Superior communication skills (written, oral and presentations) (Essential)
• Excellent problem solving, critical thinking and conflict-resolution skills (Essential)
• Exceptional attention to detail, organizational skills, and ability to prioritize multiple projects and deadlines (Essential)
• Ability to function both independently and within a team (Essential)
• High degree of professionalism and strong ability to build relationships (Essential)
• Ability to travel (as needed) (Essential)
• Bilingualism (French / English) (Asset)

Due to the nature of our work, especially as it relates to onsite work in clinical areas including hospital sites, the successful applicant must be fully vaccinated against COVID-19 (as defined by the Government of Canada) or have a valid vaccination exemption pursuant to the Human Rights Code. Further, they must provide proof of vaccination (or a valid exemption) prior to the start date, provide updated information as necessary, and comply with any ongoing vaccination-related requirements.