Research Associate coordinating 2SLGBTQI+ entrepreneurship research at the University of Alberta. Overseeing partner initiatives, community - based research, compliance, and knowledge mobilization.
About the role
- Lead CRA managing monitoring and site-management services for Alimentiv, a clinical research services company. Overseeing site activation, recruitment, data quality, regulatory documentation, and CRA mentoring across clinical studies.
Responsibilities
- Manage, deliver and/or perform full clinical site monitoring services for one or more projects, potentially involving multiple services, complex studies, and multinational projects
- Design and oversee project monitoring services, including training, site/patient recruitment, site data/document management, project site budgets, and regulatory filings aligned with SOPs, study guidelines, and GCP best practices
- Act as the primary liaison between CRAs and the project team as Lead CRA
- Participate in developing project plans, protocols, CRFs, communications, monitoring forms, documents, and tools
- Conduct and document onsite and remote site monitoring, close-out, qualification, and initiation visits
- Review study data against source documents, resolve or escalate data queries, and ensure compliance with study requirements
- Coordinate shipment and delivery of investigational products, laboratory supplies, ePROs, and study documents
- Train site staff on protocols, study plans, systems, and ICH-GCP
- Review ISF and TMF for accuracy, timeliness, and completeness; request missing site documents
- Serve as primary contact for investigational-site questions and issues
- Track site issues, action items, and protocol deviations through resolution
- Coordinate site communications and provide project, regulatory, and study updates
- Support site activation, regulatory document review/localization/translation, and study start-up
- Optimize patient recruitment and help sites meet recruitment milestones
- Participate in audits, inspections, study meetings, teleconferences, and Investigator meetings
- Mentor and support CRA I and II
- Perform CRA assessment visits, co-monitoring visits, and visit sign-off processes
- Participate in CRA interviews, process improvement initiatives, and best-practice development
Requirements
- Minimum of a college diploma/degree
- 4–6 years of related experience
- Ability to regularly travel to clinical sites
- Proficiency with EDC systems such as Medidata Rave and Oracle InForm
- Proficiency with IRT, eTMF, CTMS, and Microsoft Office Suite
- Ability to travel up to 40–60%, depending on project assignment and site geography
- Strong interpersonal and problem-solving skills
- Ability to work independently and within cross-functional teams
- Strong communication and organizational skills
- Detailed orientation and sense of urgency
- Fluency in English and French
Benefits
- Full-time, Permanent
- Bonus
- Home-based work arrangement
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