Senior Clinical Research Associate F/H

il y a 1 mois


Paris La Défense Cedex, France Orano Group Temps plein

Description de la mission

Le Senior Clinical Research Associate supervisera les activités cliniques externalisées, incluanT la gestion et la surveillance des sites, ainsi que le classement des documents TMF (Trial Master File) au niveau des sites. Des responsabilités supplémentaires peuvent être assignées, comme la gestion des laboratoires centraux.

Missions et responsabilités : 

Élaborer ou superviser l'élaboration des ICF principaux de l'étude ou du pays ; faciliter les examens internes, le cas échéant Examiner les documents destinés aux sujets (par exemple les cartes d'identité des sujets, le matériel d'instruction des sujets) pour vérifier qu'ils sont conformes au protocole, à l'IB, au consentement et à d'autres documents, le cas échéant. Superviser la surveillance des essais cliniques externalisés : en examinant les plans de surveillance, les rapports de visite de surveillance, les listes de déviations et en effectuant des visites de surveillance périodiques. Examiner le matériel de formation du site, y compris les diapositives des visites d'initiation au site et le matériel connexe.

Surveillance des activités de gestion des sites :

S'assurer que les sites respectent les Bonnes Pratiques Cliniques et que les Organisations de Recherche Clinique gèrent les déviations ou non-conformités de manière appropriée et rapide. Servir de principal point de contact pour les CRO concernant les questions relatives aux sites. Examiner les documents liés aux sites, tels que les plans de recrutement et les modifications du ICF, et veiller à une soumission rapide des documents réglementaires mis à jour.

Assurance de la qualité des données des études :

Veiller à la saisie rapide des données et à la résolution des requêtes par les sites. Fournir une documentation actualisée au niveau du site et des mises à jour applicables aux autorités réglementaires, le cas échéant (par exemple, mise à jour des 1572, communication des activations du site/des listes de sites). Orano est ouvert à tous les talents et toutes les différences.


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