Senior Project Coordinator

This is a fully remote position, open to applicants in Canada.

📋 Description

• Provide administrative and coordination support for site activation activities and deliverables at the site level throughout the clinical trial lifecycle.

• Prepare investigator sites for conducting clinical trials by reviewing and approving essential clinical trial and regulatory documents.

• Establish timelines for site activation and coordinate activities to ensure adherence to planned schedules.

• Maintain communication with clinical sites during the site start-up phase.

• Collaborate with functional departments to synchronize activities with site activation goals.

• Raise any risks concerning the site activation schedule to the Project Manager.

• Coordinate with study teams and external site personnel to align tasks and priorities with study timelines.

• Collect, review, file, and distribute essential documents from the site.

• Ensure the quality and completeness of documentation for the first-pass site activation review.

• Maintain the electronic Trial Master File (eTMF) with relevant regulatory documents.

• Produce meeting minutes and keep the ADI log updated.

• Assign project-specific training documents and manage training reconciliation and documentation.

• Assist in drafting study documents and plans.

• Act as the primary contact for non-protocol site correspondence.

• Aid sites with local ethics submissions.

• Facilitate access to study-specific systems and maintain study files.

• Assemble and dispatch Investigator Study Files and study supplies.

• Maintain project timelines, enrollment tracking tools, and inventory of study materials.

• Assist with Investigators’ Meetings.

• Provide support to CRAs during their travel.

• Review and reconcile payments to investigator sites and vendors.

• Aid in project tracking and the preparation of status reports.

• Support Health Authority inspections, pre-inspection activities, audits, and CAPA preparations.

• Carry out project management responsibilities on designated trials.

• Mentor junior Project Coordinators and assist with their onboarding.

• Encourage process improvement and the development of training materials.

⛳️ Requirements

• Minimum of 2 years of experience as a Project Coordinator or in a similar role within clinical research, biotechnology, pharmaceutical, and/or CRO industries.

• Demonstrated Site Start-Up experience in managing clinical trials and/or personnel in a global or multi-regional setting.

• Bachelor’s degree in a field pertinent to clinical research or equivalent experience.

• Strong understanding of essential documentation requirements for clinical trials.

• Proficiency in English (both written and oral) is mandatory.

• Bilingual proficiency in French and English or fluency in another European or Asian language is advantageous.

• Excellent skills in Word, Excel, and PowerPoint.

• Ability to prioritize multiple assignments to meet deadlines.

• Keen attention to detail.

• Quick learner with good adaptability and versatility.

• Strong organizational, communication, problem-solving, and multitasking abilities.

• Familiarity with good clinical practices and applicable Health Canada and FDA regulations/guidelines.

• Applicants must possess legal authorization to work in Canada.

🏝️ Benefits

• Permanent full-time position.

• Flexible work schedule.

• Home-based role.

• Ongoing learning and development opportunities.

• Comprehensive benefits package including medical, dental, and vision insurance, retirement plan, vacation, personal days, virtual medical clinic access, public transit discount, and social activities.

• Occasional visits to the head office may be required or encouraged.