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Clinical Trial Monitor/project Manager
4 weeks ago
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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 centers 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).
**RESPONSIBILITIES**
- In collaboration with the Clinical Trials Monitoring team and the MICYRN Associate Director of Clinical Trials, develop risk-based monitoring plans and corresponding budgets for clinical trial projects.
- Conduct risk-based monitoring visits either on-site or remote to investigator sites participating in pediatric clinical trials to ensure compliance with study protocols, applicable regulations, and GCP guidelines including site initiation, periodic monitoring, and site close-out visits.
- Review and verify essential documents, such as informed consent forms, case report forms (CRFs), and source documents, to ensure accuracy, completeness, and compliance.
- Identify and assess risks and issues related to study conduct, data integrity, and participant safety, and collaborate with the study team to implement corrective and preventive actions as necessary.
- Communicate effectively with investigators, site staff, and study sponsors to address queries, provide guidance on protocol requirements, and ensure timely resolution of issues.
- Prepare detailed monitoring reports documenting findings, deviations, and actions taken during monitoring visits, and maintain accurate and up-to-date trial documentation.
- Participate in study team meetings, protocol training sessions, and investigator meetings as required.
- Escalate observed deficiencies and issues to trial management expeditiously and follow all issues through to resolution.
- Assist the Clinical Trial and Quality Assurance Leads in preparing MICYRN and MICYRN member organizations for regulatory audits/inspections by Health Canada (or other regulatory bodies) as needed.
- 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.
- Assist the Clinical Trial and Quality Assurance Leads to provide clinical trial education and training sessions to MICYRN personnel and affiliated MICYRN member organizations as needed.
- Lead complex national and international maternal-child health clinical research studies and deliver project management leadership by initiating, conducting, reporting, and providing support to ensure successful project completion.
**QUALIFICATIONS**
- Undergraduate degree, preferably in a health-related discipline **[Essential]**:
- Completion of additional clinical research education and certification (eg. ACRP, SOCRA) **[Asset]**:
- Thorough knowledge of ICH-GCP, and active certifications of GCP, Health Canada Division 5 of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects”, and TCPS2 **[Essential]**:
- Minimum 5 years of experience in clinical research, with a minimum of 3 years of experience in clinical trial monitoring (either academic or industry sponsored trials) **[Essential]**:
- Previous experience conducting audits of clinical trial activities, including site/sponsor audits and regulatory inspections **[Asset]**:
- 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]**:
- 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 pro
