Senior Project Coordinator / Coordonnateur principal de projet, North America
Core
Provide administrative and coordinating support for site activation activities and other site-level deliverables throughout the clinical trial lifecycle.
Role type
Senior Project Coordinator (Clinical Research)
Builds
Site activation and maintenance for clinical trials
Domain
Biotechnology, pharmaceutical, and CRO industry
Required skills
Site start-up management, essential clinical trial documentation, regulatory compliance (Health Canada/FDA), study file management, payment reconciliation, meeting minutes, training coordination, study material inventory, shipment preparation, ethics submission support, audit preparation
Preferred skills
Mentorship of junior coordinators, process improvement, training material creation
Technologies
Word, Excel, PowerPoint, eTMF (via careerplan.io/jobs/15-003-DE-07C-senior-project-coordinator-coordonnateur-principal-de-projet-north-america-at-indero)
Responsibilities
Prepare investigator sites by reviewing and approving essential clinical trial and regulatory documents; Establish site activation timelines and coordinate activities to meet planned targets; Communicate with clinical sites during start-up; Collaborate with functional departments to align activities; Escalate risks to site activation schedules; Collect, review, and file essential site documents; Ensure eTMF contains relevant regulatory documents; Distribute study correspondence and study materials; Assist with local ethics submissions and Health Authority inspections; Maintain project timelines, enrollment tracking, and study material inventory; Assist with study document drafting and Investigators' Meetings; Mentor junior Project Coordinators.
Seniority
Senior, hands-on IC