Clinical Research Associate, Toronto, Canada, Oncology Required 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 As a CRA you will be joining the world’s largest & most comprehensive clinical research organization, powered by healthcare intelligence. En tant qu’ARC (Associé(e) de recherche clinique), vous rejoindrez la plus grande et la plus complète organisation de recherche clinique au monde, propulsée par l’intelligence en santé. 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. Your Profile: 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 What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply ICON is an award-winning workplace that enables you to make a difference to patients’ lives by being part of a world-class clinical research organisation that helps deliver new medicines & medical devices that are benefitting patients worldwide. You are also part of a diverse company that cares about our world and is dedicated to conducting business more sustainably and supporting the communities in which we live. If you’re as driven as we are, join us. You’ll be working in a great environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry. Didn’t find the role you were looking for? 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