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) Manager to support quality assurance and compliance activities within the organization and provide quality guidance and support to its member institutions, where applicable. The successful candidate will be responsible for ensuring that clinical research sponsored, managed, or supported by MICYRN adheres to applicable regulatory requirements, quality standards, and organizational policies and procedures, while supporting member organizations in strengthening their own quality management and compliance practices.

Reporting to the Director of Clinical Research, the QA Manager will oversee MICYRN's quality management program, including the development and implementation of quality assurance strategies, quality systems, audits, risk-based quality oversight, corrective and preventive action (CAPA) management, and inspection readiness activities. For MICYRN member organizations, the QA Manager will serve as a resource and advisor, providing guidance, tools, training, and consultation on quality assurance and regulatory compliance matters, and supporting quality initiatives as requested. The QA Manager will also represent MICYRN at national forums, committees, and working groups focused on research quality, quality management, and standardization initiatives, contributing to the development, harmonization, and advancement of quality practices, standard operating procedures (SOPs), and related frameworks across the Canadian clinical research landscape.

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.
- Maintain and continuously improve the MICYRN Quality Management System (QMS), ensuring quality processes, documentation, and oversight activities remain effective, up to date, and compliant with applicable regulatory and organizational requirements.
- 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.
- Support and provide quality oversight to MICYRN project management activities to ensure clinical research projects are conducted in accordance with applicable regulations, MICYRN policies, SOPs, and quality standards.
- Maintain training compliance records for MICYRN personnel and support the tracking, documentation, and monitoring of required quality, regulatory, and SOP training activities.
- 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 the review of technology products/systems (such as clinical trial management system) to support clinical research infrastructure.
- 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.
- Provide clinical research education and training sessions to MICYRN personnel and affiliated MICYRN member organizations.




- Perform other quality assurance and compliance-related duties as required.

QUALIFICATIONS

- Undergraduate degree, preferably in a health-related discipline-Essential
- Completion of additional clinical research education and certification (eg. ACRP, SoCRA)-Essential
- Minimum of 5-7 years of experience in clinical research quality assurance or monitoring within the academic, 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 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
- 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
- Experience mentoring and supervising quality assurance and monitoring personnel-Asset
- Familiarity with challenges pertaining to mothers and children in clinical research-Asset
- Experience with computerized system validation and validation of electronic systems used in clinical trials and research operations. - Asset
- Bilingualism (French / English) - Asset

_____________________________________________________________________________________

Interested candidates should submit a cover letter of interest and resume to: [email protected]

Please combine your cover letter and resume into one PDF file.

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.

Pay: $100,000.00-$120,000.00 per year

Benefits:

- Dental care
- Flexible schedule
- Vision care
- Work from home

Application question(s):

- Have you applied through the [email protected] email address? We are only reviewing applications received by email. Please submit your resume and cover letter into one PDF and send it to [email protected] for consideration.
- Do you have minimum of 5-7 years of experience in clinical research quality assurance or monitoring within the academic, pharmaceutical, biotechnology, or medical device industry?

Work Location: Remote

📌 Quality Assurance Manager (Canada)
🏢 MICYRN
📍 Canada