Clinical Trial Coordinator
On-siteMontréal, Quebec, Canada
Job Summary
Assist with the preparation and submission of regulatory documents and clinical trial materials while maintaining accurate trial documentation, including study files, regulatory binders, and essential records. Coordinate meetings, generate minutes, and support the clinical team by tracking project milestones, timelines, and deliverables. Distribute trial-related communications to sites and vendors, review payment activities for ECs/IRBs and vendors, and customize clinical site contracts and budgets. Act as the Primary Owner of the eTMF "Health Check" to ensure CRA documents are filed correctly in real-time. Collaborate on site activation documents prior to drug shipment. This role supports trial execution from initiation to close-out in compliance with GCP and company policies within AbCellera's clinical-stage biotechnology team.
Required Qualifications
- at least 2 years of demonstrated work experience in a clinical research environment, in a similar role involving coordination of clinical trial activities
- hands-on knowledge of ICH-GCP and Good Documentation Practices
Desired Qualifications
- outstanding cross-functional communicator and relationship builder
- proactive problem-solver, able to generate solutions independently
- ability to prioritize and thrive in a fast-paced environment
- operate with a high sense of accountability and accuracy
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