Clinical Research Associate

Há 5 dias


São José do Rio Preto, Brasil Novartis Tempo inteiro

SummarySurveille les données des patients et l'information liée aux études liées aux sites d'études cliniques et à la participation aux essais cliniques.S'assure que l'enquêteur adhère aux protocoles de recherche, aux exigences réglementaires et aux bonnes pratiques cliniques et donne son avis sur le plan de validation des données.Fournit une surveillance rapide et précise des données sur les patients et de l'information liée à l'étude à partir de documents sources, de dossiers de recherche et de visites sur place, le cas échéant.Surveiller, au besoin, les sites d'étude et la sélection des installations de vérification.About The RoleResponsabilités :Assure la communication entre Novartis et les centres afin de garantir une collaboration efficace, en répondant aux attentes de Novartis concernant les étapes clés et les résultats attendusAssure le management des centres investigateurs qui lui sont confiés dans le cadre de la conduite des essais de phase I-IV, conformément au plan de monitoring et aux procédures NovartisRéalise les visites d'initiation sur centre, s'assure que le personnel du site est dûment formé sur tous les aspects liés à l'essai.Assure la formation continue pour les changements et le nouveau personnel du centre au besoin.Reforme le personnel du site le cas échéantRéalise des activités de monitoring continue (sur site et à distance).Met en oeuvre des activités de gestion du site, afin de garantir la conformité avec le protocole, les bonnes pratiques cliniques, la réglementation locale et internationale et les processus locaux et internationaux afin de sécuriser l'intégrité des données et la sécurité des patientsEst responsable de la mise à jour permanente des systèmes électroniques (au niveau mondial et local) pertinents pour réaliser les fonctions inhérentes au posteS'assure que les étapes clés des études sont respectées comme prévu (c'est-à-dire, démarrage de l'étude, recrutement, analyses des bases de données, clôture, etc.)Réalise les activités de clôture des centres conformément aux SOP et à la réglementation applicable afin de s'assurer que le centre a connaissance des éventuelles activités de suivi et exigences d'archivageParticipe à l'intégration, aux formations générales et aux formations spécifiques, relatives aux indications et aux protocoles sur lesquels il travailleDocumente les activités de monitoring de manière appropriée en suivant les requis NovartisCollabore avec le Responsable ARC et les Coordinateurs d'études afin d'assurer le respect des plans de recrutement et la mise en place des plans de contingence, le cas échéantPrérequis IndispensablesDe formation scientifique supérieure Bac + 5/4Connaissance des directives ICG GCP et expertise pour examiner et évaluer les données médicalesVous posséderez une excellente communication écrite et verbale en anglaisIl vous sera demandé de voyager au moins 50% du temps et devez posséder un permis de conduire valide.Exigences SouhaitablesMinimum 2 années d'expérience similaire dans la surveillance dans des essais de phase I-III en tant qu'ARC#J-*****-Ljbffr


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