Project Coordinator I, Romania
Core
Provide administrative and coordinating support for site activation activities and other site level deliverables through all phases of the clinical trial lifecycle.
Role type
Project Coordinator (Clinical Research)
Builds
Site activation timelines, essential clinical trial documentation, study files, and meeting minutes for clinical trials.
Domain
Clinical research / Biotechnology / Pharmaceutical
Required skills
Project administration, clinical research knowledge, document management, timeline management, communication, prioritization, attention to detail, organizational skills, problem-solving, multi-tasking (via careerplan.io/jobs/15-003-DE-07A-project-coordinator-i-romania)
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 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 study file initiation and Investigator's Study File assembly; Maintain project timelines and study material inventory; Prepare shipments of study supplies; Assist with Investigators' Meeting preparation; Support CRAs and review/reconcile site and vendor payments; Participate in audit preparation and inspection support.
Seniority
Entry-level to Junior