Position Summary
The Maternal Infant Child and Youth Research Network 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).
MICYRN is seeking a Clinical Trial Monitor (CTM), responsible for Monitoring and Quality Assurance for complex national/international clinical trials and research projects, both academic and industry sponsored, in the maternal and child health space. The CTM will conduct monitoring activities across multiple Canadian sites in accordance with trial protocols and procedures, organizational and Sponsor SOPs, ICH-GCP, and applicable regulatory requirements. The CTM will be available to travel regularly (up to weekly) within Canada to support project monitoring and quality assurance needs. The CTM will liaise and build strong and co-operative relationships with multicentre investigators and their teams. The CTM will work closely with the MICYRN Clinical Trial Monitoring Lead (CTML), supporting organizational Quality Assurance initiatives and Cross Institutional Monitoring Program needs, as necessary. The CTM will report to the MICYRN Director of Operations, with functional supervision from the Associate Director, Clinical Trials. The estimated FTE required is approximately 10-20 hours per week, with the possibility to grow into a full-time position.
The successful applicant must reside within Canada (Canadian Citizen or Permanent Resident). 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
- Conduct on-site and remote monitoring activities in accordance with protocols, monitoring plans, organizational and Sponsor SOPs, ICH-GCP, and applicable regulatory requirements.
- Establish strong working relationships with a diverse group of clinical trial sites, investigators, and key stakeholders.
- Perform site Selection/Initiation/Intermittent/Close Out visits to ensure protocol adherence, regulatory compliance, REB compliance, data integrity, timeliness and quality, safety reporting, investigative product accountability and storage, Investigator Site File (ISF) maintenance, adequate site facilities, and overall compliance with research conduct.
- In collaboration with the CTML, develop and adhere to risk-based Clinical Monitoring Plans, SOPs, tools and templates; participate in assessing project status and risk, as applicable.
- In collaboration with the CTML, participate in organizational QA activities, as applicable.
- Prepare monitoring visit reports and communicate findings appropriately; identify and escalate non-compliance and poor performance to relevant MICYRN and Sponsor stakeholders.
- Prepare for and participate in regulatory/Sponsor inspections and audits, both within the organization and across investigational sites.
- Support MICYRN Cross Institutional Monitoring Program needs, as necessary.
- Participate in meetings and ongoing training requirements, as required.
- Conduct other Quality Assurance duties, as required.
Qualifications
- Undergraduate degree, preferably in a health-related discipline (Essential)
- Clinical Research Professional training/licensure (eg. ACRP, SoCRA) (Essential)
- Minimum of 5 years clinical trial monitoring and QA experience, industry-focused (Essential)
- Previous experience within the maternal and child health setting (Asset)
- Experience with local, central, and harmonized ethics boards requirements (Essential)
- Knowledge and experience with data management and clinical trial databases (Essential)
- Training and in-depth knowledge of ICH-GCP, Regulatory Requirements (Health Canada) (Essential)
- Familiarity with international clinical research guidelines, laws and standards (FDA, EMA) (Asset)
- 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 tight 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 within Canada regularly (up to weekly as needed) (Essential)
- Physical ability to carry out the duties of the position (Essential)
- Bilingualism (French / English) (Asset)
Interested candidates should submit a cover letter of interest and curriculum vitae to Karin Kushniruk, Associate Director, Clinical Trials by email: karin.kushniruk@micyrn.ca
Deadline for submission of applications is December 8, 2023.