Project Coordinator I, Romania
Core
Administrative and coordinating support for site activation activities and clinical trial lifecycle deliverables.
Role type
Project Coordinator (Clinical Research)
Builds
Site activation timelines, essential clinical trial documentation, study files, and project status reports.
Domain
Clinical research / Biotechnology / Pharmaceutical
Required skills
Project administration, Clinical research knowledge, Document management, Timeline management, Communication, Organization, Problem-solving, Multi-tasking (via careerplan.io/jobs/15-003-DE-07A-project-coordinator-i-romania-at-indero)
Preferred skills
Drug development diploma, Biotechnology/Pharmaceutical/CRO industry experience, French language, Health Authority inspection support
Technologies
Word, Excel, PowerPoint, eTMF
Responsibilities
Prepare Investigator Sites through review and approval of essential clinical trial and regulatory documents; Establish site activation timelines and coordinate activities; Communicate with clinical sites during start-up; Collect, review, and file essential site documents; Ensure eTMF contains relevant regulatory documents; Produce meeting minutes; Maintain ADI log; Assist with local ethics submissions; Assist with initiating and maintaining study files; Prepare shipments of study supplies; Review and reconcile investigator site and vendor payments; Support Health Authority inspection and audit preparation.
Seniority
Entry-level / Junior