POSITION SUMMARY
The Maternal Infant Child and Youth Research Network (MICYRN) is a federally incorporated not-for-profit charitable organization founded in 2006 to build capacity for high-quality applied health research. MICYRN connects 21 maternal and child health research organizations based at academic health centers across Canada and collaborates with more than 25 practice-based research networks affiliated with the country’s 17 medical schools.
MICYRN’s principal role is to enhance the quality and impact of research through a coordinated national infrastructure that supports research teams across Canada and internationally. In supporting clinician-scientists and investigators in maternal, perinatal, and child health, MICYRN has developed the expertise to function as a decentralized Academic Research Organization (ARO).
MICYRN is seeking a full-time Clinical Trial Monitor for the Eastern Canada region. This role is critical to ensuring participant safety, data integrity, and study quality through both on-site and remote risk-based monitoring. The role is now positioned as a partner to member institutions, supporting not only compliance monitoring but also the advancement of clinical research capability across the network.
The successful candidate will work closely with study teams and MICYRN member institutes, providing oversight, guidance, and support to ensure clinical trials are conducted in accordance with approved protocols, ICH-GCP guidelines, applicable regulations, and MICYRN Standard Operating Procedures (SOPs). The role plays a key part in safeguarding participant rights and well-being while ensuring data are accurate, complete, and verifiable.
The Clinical Trial Monitor will serve as a key resource and trusted advisor to MICYRN member institutions, providing clinical research guidance, quality oversight, and operational support to strengthen clinical trial capacity across the network. The successful candidate will build and maintain strong relationships with research teams, investigators, clinical research offices, and institutional partners to support the successful delivery of high-quality clinical trials.
While the primary focus is on academic, investigator-initiated trials, the role may also support biotech and industry-sponsored studies as needed.
This position reports to the Director of Clinical Research and operates within MICYRN’s distributed Coordinating Centre model. This hybrid position involves regular travel to conduct monitoring visits. Given the regional responsibilities of the role, applicants must reside in Eastern Canada.
This is a dynamic and evolving role with strong opportunities for professional growth. In addition to monitoring activities, the incumbent may support MICYRN member institutes by performing internal audit activities and audit readiness support. MICYRN is currently enhancing its risk-based monitoring program and is seeking a motivated and forward-thinking individual to contribute to this evolution and support organizational priorities outlined in the annual business plan.
The successful applicant must reside within Canada (Canadian citizen or permanent resident) and be available to travel on a regular basis.
RESPONSIBILITIES
- Conduct risk-based monitoring activities (remote and on-site) at investigator sites participating in pediatric clinical trials, including site initiation, routine monitoring, and close-out visits, to ensure compliance with study protocols, ICH-GCP guidelines, and applicable regulatory requirements.
- Review and verify essential trial documents (e.g., informed consent forms, case report forms [CRFs], and source documents) to ensure accuracy, completeness, and data integrity.
- Identify, assess, and communicate risks related to study conduct, participant safety, and data quality, and collaborate with study teams and sponsors to implement appropriate corrective and preventive actions (CAPAs).
- Prepare comprehensive monitoring reports, documenting findings, deviations, and follow-up actions, ensuring timely tracking and resolution of issues; and review and validate monitoring reports from MICYRN’s contract monitors for accuracy.
- Maintain and regularly update the MICYRN monitoring tracker, including tracking upcoming monitoring visits and supporting contract monitors by responding to queries and coordinating monitoring activities.
- Communicate effectively with investigators, site staff, sponsors, and MICYRN member institutes to provide guidance on protocol requirements, resolve queries, and support high-quality trial conduct.
- Escalate significant findings, non-compliance, or safety concerns to trial leadership in a timely manner and ensure issues are followed through to resolution.
- Support MICYRN member institutes by conducting independent internal audits, as required, and assisting study teams with audit readiness and preparation for regulatory inspections (e.g., Health Canada or other regulatory bodies).
- Participate in study team meetings, investigator meetings, and protocol training sessions as required.
- Contribute to the ongoing enhancement of MICYRN’s monitoring and quality assurance program, including process improvements, tools, templates, and SOP development.
- Engage in QA initiatives, working groups, and continuous learning to remain current with regulatory expectations, inspection trends, and best practices.
- Support the delivery of clinical trial monitoring and quality assurance training for MICYRN staff and member institutes, as needed.
- Perform other clinical trial–related duties, as needed, to support MICYRN’s evolving organizational needs.
- Develop and maintain strong, collaborative relationships with MICYRN member institutions, investigators, research offices, clinical research teams, and other institutional stakeholders.
- Serve as a clinical research resource and advisor to member institutions, providing guidance on monitoring expectations, ICH-GCP requirements, quality standards, and best practices.
- Provide coaching and practical guidance to research teams to enhance readiness for monitoring visits, audits, and regulatory inspections.
QUALIFICATIONS
Education
- Undergraduate degree, preferably in a health-related discipline
Essential
- Completion of clinical research certification (e.g., ACRP, SOCRA)
- Thorough knowledge of ICH-GCP, with active certifications in GCP, Health Canada Division 5 (Food and Drug Regulations – Drugs for Clinical Trials Involving Human Subjects), and TCPS2
- Minimum 5 years of experience in clinical research, including at least 3 years in clinical trial monitoring (academic and/or industry-sponsored trials)
- In-depth knowledge of clinical trial methods, conduct, and execution
- Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS)
- Intermediate proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook) and videoconferencing tools (Zoom, Microsoft Teams)
- Demonstrated ability to work independently in a remote or hybrid work environment
- Strong written, verbal, and presentation communication skills
- Excellent problem-solving, critical thinking, and conflict-resolution skills
- Exceptional attention to detail, organizational skills, and ability to manage multiple priorities and deadlines
- Ability to function both independently and within a team
- High degree of professionalism and strong ability to build relationships
- Ability to travel
Assets
- Experience conducting clinical trial audits, including site, sponsor, or regulatory inspections
- Knowledge of Health Canada regulatory approval processes
- Experience in monitoring device clinical trials and trials involving natural health products and cannabis
- Bilingualism (French/English)
How to apply?
- 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.
Job Types: Full-time, Permanent
Pay: $90,000.00-$110,000.00 per year
Application question(s):
- Do you have minimum 5 years of experience in clinical research, including at least 3 years in clinical trial monitoring (academic and/or industry-sponsored trials) ?
- Do you have a willingnes to travel regularly within central and eastern Canada?
- Are you located in Eastern Canada?
- 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.
Work Location: Hybrid remote in Vancouver, BC
