Project Coordinator II-Canada

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The Project Coordinator II provides coordination and operational support for site activation and maintenance activities across all study phases. This role demonstrates greater autonomy and ownership, with accountability for assigned projects and deliverables. The PC II ensures timely and accurate completion of site-level and project documentation, proactive communication, and compliance with study timelines.

This role is perfect for you if:

• You have an experience in project administration and clinical research;
• You want to work in a collaborative environment;
• You want to have an impact in a fast-growing company.

RESPONSIBILITIES

More specifically, the Project Coordinator II:

• Lead assigned site activation activities, ensuring delivery within established timelines and quality standards.
• Coordinate, collect, review, and approve essential regulatory and clinical trial documents from investigator sites.
• Act as the primary point of contact for assigned sites on operational and administrative matters.
• Communicate effectively with internal teams (e.g., Clinical Operations, Regulatory, Data Management) to align priorities and address issues impacting activation or maintenance.
• Identify potential risks or delays in site activation and escalate to the Project Manager as appropriate.
• Ensure that essential documents are accurate, complete, and compliant for first-pass review and site activation.
• Maintain up-to-date information in the CTMS, eTMF, and other tracking tools.
• Prepare meeting minutes, study trackers, and reports for internal and client updates.
• Support ethics committee submissions and country-specific regulatory requirements when applicable.
• Coordinate training assignments and maintain documentation for project-specific training activities.
• Prepare and distribute study correspondence, site communications, and tracking documentation.
• Manage logistics related to investigator meetings, study supplies, and ISF distribution.
• Participate in audits and inspections, providing relevant documentation and supporting responses to findings.
• Contribute to process improvements, best practice documentation, and SOP compliance initiatives within the Project Coordination team.
• Provide guidance to junior coordinators on standard processes and administrative activities

IDEAL PROFILE

• Bachelor’s degree in a field relevant to clinical research or equivalent experience.
• 1 to 2 years of experience in clinical research, preferably in a CRO, biotech, or pharmaceutical setting.
• Sound understanding of GCP, ICH guidelines, and clinical documentation standards.
• Strong interpersonal and organizational skills, with the ability to prioritize and manage multiple tasks.
• Excellent written and verbal communication skills in English; bilingualism an asset.
• Demonstrated ability to work independently and collaboratively within cross-functional teams.
• Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.