Summary Senior CRA with regulatory submission responsibilities, worked in CRO at local level within single/multicentric Clinical Trials (phase 1-3 and Bioavailability Studies) and coordinating all process: feasibility studies, sites identification, contracts negotiations with PI/hospital administration, collection of documents and CT dossier preparation, submission to Regulatory Agencies, preparation/submission of Amendments and Notifications, Site Initiation visits, Monitoring visits and Close Out Visits. Currently looking to progress into a more senior role. Dumitru Badicean

Highlights:

• CT
• Management
• Project Management
• Collection
• Documentation
• English Language
• Foreign Languages
• Good Clinical Practices
• Hospital Administration
• Monitoring