Clinical Trial Project Lead

This position has a term length of 1 year plus 1 day.

Location - This role is hybrid with a mix of remote and in-person work at North Campus Edmonton.

The Clinical Trials Project Lead (CTPL) develops, implements, manages, and evaluates research and administrative strategies essential to successfully conducting local, national and international clinical trial projects. The successful candidate leads project teams and research site personnel located at participating sites across Canada on one or multiple projects. This position assumes responsibility for the clinical trial projects' overall operation, coordination and project management aspects. It is responsible for reporting trial status, metrics and performance to academic partners, sponsors and trial leadership.

• Monitors, assesses and manages project status on an ongoing basis to ensure project objectives are met in a timely, cost-efficient manner.
• Assesses and communicates project resource requirements, proactively anticipate project issues and develops ongoing resolution strategies to ensure successful project completion.
• Develops project protocols and associated plans and materials with the National Director and other research team members. Contributes to the ongoing review and modification of protocols to ensure continuing relevancy and subject safety.
• Provides leadership and guidance to research sites to ensure that each project complies with sponsor timelines, study protocols, Standard Operating Procedures (SOPs), ethics guidelines and other applicable regulatory requirements
• Develops project plans. Proactively anticipates project issues and develops strategies for resolution on an ongoing basis to ensure successful project completion on time and on budget. Responsible for ensuring all trial-related activities are delivered within the trial timelines as laid out in the scope of work.
• Proactively assesses risk, analyzes identified issues as they arise and provides effective solutions for the successful project continuation; communicates any resulting revised procedures/protocols to all participating project sites to ensure consistency.
• Works with project team members in identifying priority tasks and providing expertise and team leadership.
• Responsible for ensuring all operational aspects of the project are completed and accurately documented throughout each phase of the study, including site identification/feasibility, site selection, start-up process with each site, regulatory completeness, site activation, ensuring ongoing site recruitment and enrollment are in line with the study projections, ensuring follow up regularly with sites through the enrollment and follow up period on data entry, ensuring timelines are met for database lock and working closely with sites through closeout and archival of the study.

• Minimum of an undergraduate degree in science or health-related field; BScN is desirable.
• An advanced degree and/or completion of additional clinical research education (e.g., ACRP, SoCRA) 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; 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.

Additional Preferred Qualifications:

• Bilingual English/French is an asset
• Intermediate computer experience: MS Word, MS Excel, MS PowerPoint, Gmail, SharePoint, Clinical Trial Management System (CTMS).
• Data management experience with Clinical Trial Databases (INFORM, RAVE, RedCAP)

Application Instructions

Click "Apply Now" to submit your resume and cover letter.

This position is subject to all applicable terms and conditions of the collective agreement between the Governors of the University of Alberta and the Non-Academic Staff Association (NASA).

This position offers a comprehensive benefits package.