Clinical Research Associate II

5 days ago

Ontario, Canada ICON Strategic Solutions Full time

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.


What you will be doing:

  • 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 atteindre les cibles de verrouillage de la base de données en temps opportun.
  • Mettre en œuvre les activités de clôture des centres d’étude et rédiger le rapport de clôture des centres d’étude.
  • Fournir des commentaires sur les performances des centres d’étude afin d’évaluer leur candidature pour de futures études cliniques.


You are:

  • Bachelor’s Degree or higher in life sciences or equivalent
  • Minimum 2 years’ clinical site monitoring experience from CRO or Pharmaceutical company
  • Comprehensive knowledge and understanding of ICH-GCP
  • Able and willing to travel up to 60% regionally (sites in Quebec City and Montreal)
  • Able and willing to work on several protocols/therapy areas
  • Experience in phase I-IV trials
  • Working knowledge of Electronic Data Capture (preferred)
  • Experience/working knowledge of the oncology disease area (preferred but not required)
  • Experience of Centralized/Risk Based/Targeted monitoring (preferred)
  • Experience of working within a metric based environment (preferred)
  • Excellent attention to detail
  • Highly developed time management and organizational skills
  • Focused on meeting study deliverables/targets
  • Flexible and willing to adapt to changing priorities/timelines
  • Experience in oncology is required
  • Blingual English/French Required

Compétences

  • Baccalauréat ou diplôme supérieur en sciences de la vie ou un équivalent
  • Minimum de 2 à 4 ans d’expérience en surveillance de centres d’étude pour une entreprise de recherche contractuelle ou une société pharmaceutique
  • Des connaissances et une compréhension approfondies des bonnes pratiques cliniques élaborées par la Conférence internationale sur l’harmonisation (BPC-CIH)
  • Bilinguisme français/anglais (maîtrise verbale et écrite) exigé
  • Disposé(e) et apte à voyager jusqu’à 60 % du temps à l’échelle régionale (centres d’étude à Québec et à Montréal)
  • Disposé(e) et apte à travailler sur plusieurs protocoles/domaines thérapeutiques
  • Expérience dans les études cliniques de phase I à IV
  • Connaissance pratique de la saisie électronique des données (préférable)
  • Expérience/connaissance pratique dans le domaine des maladies oncologiques (préférable, mais non requise)
  • Expérience dans la surveillance centralisée/axée sur les risques/ciblée (préférable)
  • Expérience de travail dans un environnement métrique (préférable)
  • Souci du détail
  • Compétences organisationnelles et de gestion du temps de haut niveau
  • Déterminé(e) à fournir les livrables et atteindre les objectifs des études
  • Flexible et disposé(e) à s’adapter aux changements dans les priorités/échéanciers

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