Nanterre, Île-de-France, France
Main tasks : - Collection of regulatory documents - EC and CA submissions under CTR through CTIS platform - Creation and customization of informed consent documents - Communication with sites to conduct and facilitate the start-up activities and maintain an active collaboration during maintenance and close-out - Preparation and negotiation of clinical sites contracts and budgets Additional activities : - Subject Master Expert (SME) on translation management, Informed Consent Forms and security transfert - Involved in the CDMS migration working group for submission and contract management. - Lead TCA (trial capabilities associate) on 2 oncology studies - Involved in portfolio calls - Principal Point of Contact (PPC) role in EMEA: key contact for TCAs and study team, who leads the different aspects of clinical start-up strategy, submission, sites activation, maintenance and closeout oversight. - Mentor of newcomers
- CRA working on a wide range of pathologies: oncology, rheumatology cardiology, neurology,... - Selection, site initiation, monitoring and close-out visits - Clinical supply management with vendors and project team - Help on protocol finalization, in discussion with medical team and study team