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Study Coordinator
vor 1 Woche
**Study Coordinator / ARC Coordinateur**
**Responsabilités**:
- Participer à l'élaboration de plans stratégiques pour les activités opérationnelles et à la stratégie de leur mise en place (protocole, cahier d'observation, plan d'études )
- Assurer l'archivage de la documentation de l'étude clinique et des documents administratifs et réglementaires
- Réaliser le contrôle qualité sur site et la relecture de rapports de monitoring
- En charge du contrôle qualité des données de l'étude clinique collectés
- La coordination des CRO et des prestataires/partenaires, en charge des activités cliniques de l'étude, et en lien avec le chef de projet global
- La coordination du monitoring, avec notamment la formation et le suivi des ARCs et la validation des rapports de visite.
- Le suivi de la gestion des centres investigateurs
- La participation à l'organisation et à la préparation des réunions (ARCs et investigateurs) en collaboration avec les autres membres de l'équipe de l'étude
- la rédaction et/ou la validation de tous les documents nécessaires pour superviser la mise en œuvre, le suivi et les rapports de l'activité clinique (tels que le plan de monitoring ).
- Participer à l'évaluation, la gestion et la documentation des risques/déviations potentiels du projet, y compris la probabilité et l'impact
- Réaliser le reporting au Chef de Projets Cliniques et au Responsable des Opérations Cliniques
- Préparation, organisation et participation à des réunions internes ou externes
**Profile**:
- Minimum 5 années d'expérience en opérations cliniques dans l'industrie pharmaceutique ou en CRO,
- Bon(ne) communiquant(e), polyvalent(e) et travaillant en équipe.
- Vous avez acquis de solides compétences dans la conduite d'études cliniques.
- Expérience dans la rédaction des documents d'études cliniques pour la mise en place, le suivi et la clôture serait un plus.
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