BORDEAUX2007 - maintenant•Phase I/II – National studies, oncology: multicentric trials
• Project conception: writing of scientific documents, guidelines for conducting the trial, SOP
• Coordination
• Initiation, Monitoring, Close-out visits
• Administrative and financial follow up (contracts, conventions) in collaboration with our regulatory department
• Interaction with International team (email, conference...)
• eCRF training : Investigators and study nurses (eCRF MACRO, study eCRF ; CDUS database/NCI)
• Interaction with Data Management (CRF development, queries, respect of the delay of database lock and intermediate analysis)
• Management of clinical trial treatment (sending, accountability, storage)
• Training to the local and international procedures
• CRA Training
• Management and reporting of SAEs
• Speaker at conferences
• Teaching
• Team training
• Team management
