Clinical Research Assistant
2 weeks ago
Fonction
L'assistant de recherche clinique travaillera sous l'autorité du Dr Imran Ahmad et sous la responsabilité du Dr Jean Roy, titulaire de la Chaire Maryse et William Brock pour la recherche clinique en greffe de cellules hématopoïétiques de l'Université de Montréal. Cette personne participera à divers niveaux à la faisabilité, la mise en place, la tenue et la fermeture d'études cliniques en greffe de cellules hématopoïétiques et thérapie cellulaire provenant principalement de chercheurs locaux.
Responsabilités
- Participe à l'évaluation de la faisabilité de futures études cliniques
- Collabore à l'écriture de protocoles de recherche clinique initiés par des chercheurs locaux
- Révise et adapte les formulaires d'informations et de consentements des nouvelles études et lors d'amendements en fonction des standards locaux
- Réalise la mise en place et la tenue d'études cliniques afin d'assurer leur bon déroulement
- Complète, révise et maintient les documents réglementaires et éthiques dans le cadre d'études cliniques
- Prépare des documents pour les soumissions éthiques et réglementaires et contribue à obtenir les approbations requises des divers comités pour la mise en place d'études cliniques
- Réalise l'évaluation budgétaire d'études cliniques et assure le suivi financier des études cliniques sous sa responsabilité
- Collabore avec l'équipe légale pour la révision d'ententes
- Procède à la vérification de données collectées lors d'études rétrospectives ou prospectives, réalise des analyses statistiques, et présente les données sous forme de tableaux et de graphiques
- Aide à l'écriture et à la soumission d'articles et d'abrégés scientifiques
- Collabore à la soumission de demandes de subventions auprès des organismes subventionnaires et de sociétés pharmaceutiques pour des études initiées pas des chercheurs locaux
- Assure la communication avec les promoteurs et ses partenaires et répond à leurs demandes efficacement
- Collabore avec les membres de l'unité, l'administration de la recherche et les services de l'institution pour assurer le bon fonctionnement des études en cours
- S'assure que le travail est réalisé en conformité aux protocoles, à la réglementation applicable, aux Bonnes Pratiques Cliniques et aux modes opératoires standardisés afin d'atteindre les plus hauts standards de qualité
- Collabore avec les membres de l'unité, le personnel des sites participants, des compagnies pharmaceutiques et des organisations de recherche contractuelles (CRO)
- Participe aux réunions de projet pour maintenir un haut standard de qualité
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