Clinical Research Associate
2 months ago
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
The Clinical Research Associate (CRA) monitors the progress of clinical studies at investigative sites or remotely, ensuring clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), International Conference on Harmonization Good Clinical Practices (ICH-GCP) and all applicable regulatory requirements.
ICON plc est un chef de file mondial en matière de renseignements en soins de santé et de recherche clinique. De la molécule au médicament, nous faisons progresser la recherche clinique en offrant des services externalisés aux entreprises pharmaceutiques, biotechnologiques et d’équipement médical, ainsi qu’aux organismes gouvernementaux et de santé publique. En plaçant nos patients au cœur de toutes nos activités, nous contribuons à accélérer le développement de médicaments et de dispositifs, qui sauvent des vies et améliorent la qualité de vie. Nos employé(e)s sont le fer de lance de notre culture et constituent la force motrice de notre succès. Les employé(e)s d’ICON ont pour mission de réussir et sont animé(e)s d’une passion qui garantit que ce que nous faisons, nous le faisons bien.
**Résumé général**
L’associé(e) de recherche clinique (ARC) surveille l’avancement des études cliniques aux centres de recherche ou à distance, en veillant à ce que les essais cliniques soient menés, enregistrés et signalés conformément au protocole, aux procédures opérationnelles normalisées, aux bonnes pratiques cliniques de la Conférence internationale sur l’harmonisation (BPC-CIH), et à toutes les exigences réglementaires applicables.
**Responsibilities**:
- Contribute to the identification of new sites for clinical trials
- Assume ambassadorial role to facilitate communication between sites and sponsor CPO to increase value proposition to investigators.
- Facilitate the preparation and collection of site and country level documents during all phases of the trial. Supports the Clinical Study Manager in the oversight of Country and Site Trial Master Files (TMF). During all phases of the trial ensure archiving per relevant SOP.
- Execute site initiation and training, generate initiation visit report.
- Implement complete site management including monitoring visits, regulatory assessment, drug supply management, etc. to ensure compliance with protocol, GCP, global and local regulations, global and local processes.
- Identify problems at sites; resolve issues and escalate as appropriate.
- Complete preparation and generation of visit monitoring reports as per relevant SOP.
- Review and manage data at site; resolve technical and content issues on a continuous basis in order to achieve timely database lock targets.
- Implement site close-out activities and generate site close-out report.
- Provide feedback on site performance for future trial site feasibility/selection
- Improve skills by timely completion performance of assigned global and local training.
**Responsabilités**:
- Contribuer à l’identification de nouveaux centres pour des études cliniques
- Assumer un rôle d’ambassadeur pour faciliter les communications entre les centres d’étude et le Directeur de l’expérience patient du promoteur, afin de rehausser la proposition de valeur aux chercheurs.
- Faciliter la préparation et la collecte des documents aux centres d’étude et à l’échelle du pays pendant toutes les phases d’étude. Soutenir le travail du gestionnaire de l’étude clinique pour la surveillance des fichiers maîtres de l’étude (FME) aux centres d’étude et à l’échelle du pays. Pendant toutes les phases d’étude, s’assurer que l’archivage est conforme aux procédures d’exploitation normalisées.
- Effectuer l’initiation des centres d’étude et la formation du personnel, rédiger le rapport de la visite d’initiation.
- Mettre en place la structure complète de gestion des centres d’étude, entre autres, les visites de surveillance, les évaluations réglementaires, la gestion de l’approvisionnement en médicaments, pour assurer la conformité au protocole, aux BPC, aux réglementations mondiales et locales, et aux processus mondiaux et locaux.
- Identifier les problèmes aux centres d’étude; résoudre les problèmes et les communiquer à un palier supérieur de la direction, le cas échéant.
- Effectuer la rédaction complète et la distribution des rapports sur les visites de surveillance, conformément aux procédures d’exploitation normalisées pertinentes.
- Examiner et gérer continuellement les données recueillies aux centres d’étude, afin de résoudre rapidement les problèmes techniques et de contenu pour att
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