Project Coordinator I, Argentina
Core
Provide administrative and coordinating support for site activation activities and other site-level deliverables throughout the clinical trial lifecycle.
Role type
Project Coordinator (Clinical Trials)
Builds
Site activation timelines, essential clinical trial documentation, study files, and meeting minutes.
Domain
Clinical Research / Biotechnology / Pharmaceutical
Required skills
Project administration, clinical research knowledge, document management, timeline coordination, communication, prioritization, attention to detail, organizational skills, problem-solving, multi-tasking
Preferred skills
Specialized graduate diploma in drug development, experience in biotechnology/pharmaceutical/CRO industry, French language skills
Technologies
Microsoft Word, Excel, PowerPoint, electronic Trial Master File (eTMF)
Responsibilities
Prepare Investigator Sites by reviewing and approving essential clinical trial and regulatory documents; Establish site activation timelines and coordinate activities to meet planned dates; 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 documentation quality for first-pass review; Maintain eTMF with relevant regulatory documents; Collect and distribute documents from/to sites; Produce meeting minutes; Maintain ADI log; Assist with drafting study documents and plans; Act as main contact for non-protocol site correspondences; Assist with local ethics submissions; Assist teams with access to study-specific systems; Initiate and maintain study files; Assemble and ship Investigator's Study Files; Maintain project timelines, enrollment tracking, and study material inventory; Prepare shipments of study supplies; Assist with Investigators' Meetings; Distribute study correspondence; Support CRAs; Review and reconcile site and vendor payments; Assist with project tracking and status reports; Support Health Authority inspections and audit preparations.
Seniority
Entry-level to Mid-level, hands-on IC (via careerplan.io/jobs/15-003-DE-079-project-coordinator-i-argentina)