Senior Project Coordinator

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

📋 Description

• Deliver administrative and coordination support for site activation activities and other site-specific deliverables throughout all stages of the clinical trial lifecycle.

• Spearhead initiatives to ensure timelines, targets, and the quality of deliverables align with both internal and external customer expectations.

• Collaborate with Project Managers, Clinical Trial Managers, Site Selection Teams, and Clinical Research Associates.

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

• Set site activation timelines and coordinate activities to meet established activation schedules.

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

• Work together with functional departments to synchronize activities with site activation goals.

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

• Engage with study teams and external site staff to align tasks and priorities with study timelines.

• Gather, review, file, and distribute critical site documents.

• Ensure the eTMF contains pertinent regulatory documents for site activation and ongoing study management.

• Generate meeting minutes and maintain the ADI log.

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

• Aid in drafting study documents and study plans.

• Act as the primary contact for site correspondence on issues unrelated to the protocol.

• Assist sites with local ethics submissions and provide teams access to study-specific systems.

• Initiate and manage study files.

• Assemble and dispatch Investigator’s Study Files.

• Maintain project timelines, enrollment tracking tools, and study material inventories.

• Prepare shipments of study supplies to clinical sites as necessary.

• Support Investigators’ Meetings.

• Serve as an in-house contact to assist CRAs during travel.

• Review and reconcile payments for investigator sites and vendors.

• Help with project tracking and the preparation of status reports.

• Support Health Authority inspections, pre-inspection activities, audit preparation, and CAPA preparation as required.

• Perform project management tasks on designated trials as needed.

• Mentor junior Project Coordinators and assist with their onboarding.

• Contribute to process improvements and the development of training materials.

⛳️ Requirements

• A minimum of 2 years of experience as a Project Coordinator or in a comparable role within clinical research, specifically in the biotechnology, pharmaceutical, and/or CRO sectors.

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

• Bachelor's degree in a field related to clinical research or equivalent experience.

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

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

• Strong proficiency in Word, Excel, and PowerPoint.

• Capability to prioritize multiple tasks to meet deadlines.

• Keen attention to detail.

• Quick learner with good adaptability and versatility.

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

• Solid understanding of good clinical practices and relevant Health Canada and FDA regulations/guidelines.

🏝️ Benefits

• Flexible working hours.

• Permanent full-time employment.

• Comprehensive company benefits package.

• Continuous learning and development opportunities.

• Attractive opportunities for advancement.

• Engaging work environment.