Technical Services Coordinator organizing field and workshop maintenance services for Canadian customers. Planning routes, quotes, billing, suppliers, and technician schedules.
About the role
- Clinical Trial Project Lead managing multi-site clinical research for the University of Alberta’s academic health sciences faculty. Coordinating protocols, sites, regulatory compliance and trial delivery.
Responsibilities
- Develop, implement, manage and evaluate research and administrative strategies for clinical trial projects
- Lead project teams and research site personnel across participating sites in Canada and internationally
- Monitor, assess and manage project status to meet objectives on time and within budget
- Assess resource requirements, anticipate project issues and develop resolution strategies
- Develop project protocols, plans and supporting materials with the National Director and research team
- Review and modify protocols to maintain relevance and subject safety
- Provide leadership and guidance to research sites regarding sponsor timelines, protocols, SOPs, ethics guidelines and regulatory requirements
- Assess risks, analyze issues and communicate revised procedures or protocols to participating sites
- Identify priority tasks and provide project expertise and team leadership
- Manage operational activities including site feasibility and selection, start-up, regulatory completeness, site activation, recruitment, enrollment, data entry follow-up, database lock, closeout and archival
- Report trial status, metrics and performance to academic partners, sponsors and trial leadership
- Ensure accurate documentation throughout each study phase
Requirements
- Minimum of an undergraduate degree in science or health-related field; BScN is desirable
- Minimum four years of clinical trial experience, including site monitoring and project coordination responsibilities
- In-depth knowledge of clinical trial and drug development processes
- Knowledge of ICH-GCP, FDA and Health Canada regulatory requirements
- Demonstrated ability to manage multiple projects and cross-functional teams
- Well-developed interpersonal communication skills, both oral and written
- Team building skills and ability to work successfully in a team environment
- Bilingual English/French is an asset
- Intermediate computer experience with MS Word, MS Excel, MS PowerPoint, Gmail, SharePoint and Clinical Trial Management Systems (CTMS)
- Data management experience with Clinical Trial Databases (INFORM, RAVE, RedCAP)
- An advanced degree and/or additional clinical research education such as ACRP or SoCRA is desirable
Benefits
- Comprehensive benefits package
- Terms and conditions of the collective agreement between the Governors of the University of Alberta and the Non-Academic Staff Association (NASA)
- Hybrid work arrangement with remote and in-person work
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