Job Description

OverviewICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.ResponsibilitiesICON ISS is searching for bilingual Clinical Research Associate IIs (CRA II / Field Monitor) in Montreal, QC, Canada to work on complex and exciting trials for a major sponsor.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.

Responsabilit\xc3\xa9s:

• Contribuer \xc3\xa0 lidentification de nouveaux centres pour des \xc3\xa9tudes cliniques
• Assumer un r\xc3\xb4le dambassadeur pour faciliter les communications entre les centres d\xc3\xa9tude et le Directeur de lexp\xc3\xa9rience patient du promoteur, afin de rehausser la proposition de valeur aux chercheurs.
• Faciliter la pr\xc3\xa9paration et la collecte des documents aux centres d\xc3\xa9tude et \xc3\xa0 l\xc3\xa9chelle du pays pendant toutes les phases d\xc3\xa9tude. Soutenir le travail du gestionnaire de l\xc3\xa9tude clinique pour la surveillance des fichiers ma\xc3\xaetres de l\xc3\xa9tude (FME) aux centres d\xc3\xa9tude et \xc3\xa0 l\xc3\xa9chelle du pays. Pendant toutes les phases d\xc3\xa9tude, sassurer que larchivage est conforme aux proc\xc3\xa9dures dexploitation normalis\xc3\xa9es.
• Effectuer linitiation des centres d\xc3\xa9tude et la formation du personnel, r\xc3\xa9diger le rapport de la visite dinitiation.
• Mettre en place la structure compl\xc3\xa8te de gestion des centres d\xc3\xa9tude, entre autres, les visites de surveillance, les \xc3\xa9valuations r\xc3\xa9glementaires, la gestion de lapprovisionnement en m\xc3\xa9dicaments, pour assurer la conformit\xc3\xa9 au protocole, aux BPC, aux r\xc3\xa9glementations mondiales et locales, et aux processus mondiaux et locaux.
• Identifier les probl\xc3\xa8mes aux centres d\xc3\xa9tude; r\xc3\xa9soudre les probl\xc3\xa8mes et les communiquer \xc3\xa0 un palier sup\xc3\xa9rieur de la direction, le cas \xc3\xa9ch\xc3\xa9ant.
• Effectuer la r\xc3\xa9daction compl\xc3\xa8te et la distribution des rapports sur les visites de surveillance, conform\xc3\xa9ment aux proc\xc3\xa9dures dexploitation normalis\xc3\xa9es pertinentes.
• Examiner et g\xc3\xa9rer continuellement les donn\xc3\xa9es recueillies aux centres d\xc3\xa9tude, afin de r\xc3\xa9soudre rapidement les probl\xc3\xa8mes techniques et de contenu pour atteindre les cibles de verrouillage de la base de donn\xc3\xa9es en temps opportun.
• Mettre en \xc5\x93uvre les activit\xc3\xa9s de cl\xc3\xb4ture des centres d\xc3\xa9tude et r\xc3\xa9diger le rapport de cl\xc3\xb4ture des centres d\xc3\xa9tude.
• Fournir des commentaires sur les performances des centres d\xc3\xa9tude afin d\xc3\xa9valuer leur candidature pour de futures \xc3\xa9tudes cliniques.

QualificationsQualifications

• Bachelors Degree or higher in life sciences or equivalent
• Minimum 2 - 4 years clinical site monitoring experience from CRO or Pharmaceutical company
• Comprehensive knowledge and understanding of ICH-GCP
• Bilingual (verbal and written) in English and French languages required
• 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

Comp\xc3\xa9tences

• Baccalaur\xc3\xa9at ou dipl\xc3\xb4me sup\xc3\xa9rieur en sciences de la vie ou un \xc3\xa9quivalent
• Minimum de 2 \xc3\xa0 4 ans dexp\xc3\xa9rience en surveillance de centres d\xc3\xa9tude pour une entreprise de recherche contractuelle ou une soci\xc3\xa9t\xc3\xa9 pharmaceutique
• Des connaissances et une compr\xc3\xa9hension approfondies des bonnes pratiques cliniques \xc3\xa9labor\xc3\xa9es par la Conf\xc3\xa9rence internationale sur lharmonisation (BPC-CIH)
• Bilinguisme fran\xc3\xa7ais/anglais (ma\xc3\xaetrise verbale et \xc3\xa9crite) exig\xc3\xa9
• Dispos\xc3\xa9(e) et apte \xc3\xa0 voyager jusqu\xc3\xa0 60 % du temps \xc3\xa0 l\xc3\xa9chelle r\xc3\xa9gionale (centres d\xc3\xa9tude \xc3\xa0 Qu\xc3\xa9bec et \xc3\xa0 Montr\xc3\xa9al)
• Dispos\xc3\xa9(e) et apte \xc3\xa0 travailler sur plusieurs protocoles/domaines th\xc3\xa9rapeutiques
• Exp\xc3\xa9rience dans les \xc3\xa9tudes cliniques de phase I \xc3\xa0 IV
• Connaissance pratique de la saisie \xc3\xa9lectronique des donn\xc3\xa9es (pr\xc3\xa9f\xc3\xa9rable)
• Exp\xc3\xa9rience/connaissance pratique dans le domaine des maladies oncologiques (pr\xc3\xa9f\xc3\xa9rable, mais non requise)
• Exp\xc3\xa9rience dans la surveillance centralis\xc3\xa9e/ax\xc3\xa9e sur les risques/cibl\xc3\xa9e (pr\xc3\xa9f\xc3\xa9rable)
• Exp\xc3\xa9rience de travail dans un environnement m\xc3\xa9trique (pr\xc3\xa9f\xc3\xa9rable)
• Souci du d\xc3\xa9tail
• Comp\xc3\xa9tences organisationnelles et de gestion du temps de haut niveau
• D\xc3\xa9termin\xc3\xa9(e) \xc3\xa0 fournir les livrables et atteindre les objectifs des \xc3\xa9tudes
• Flexible et dispos\xc3\xa9(e) \xc3\xa0 sadapter aux changements dans les priorit\xc3\xa9s/\xc3\xa9ch\xc3\xa9anciers

Benefits of Working in ICON:Our success depends on the knowledge, capabilities and quality of our people. Thats why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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.Les avantages de travailler pour ICON:Notre succ\xc3\xa8s d\xc3\xa9pend des connaissances, des capacit\xc3\xa9s et de la qualit\xc3\xa9 de notre personnel. Cest pourquoi nous nous engageons \xc3\xa0 former nos employ\xc3\xa9(e)s dans une culture dapprentissage continu une culture o\xc3\xb9 nous vous mettons au d\xc3\xa9fi de faire du travail int\xc3\xa9ressant et o\xc3\xb9 chaque exp\xc3\xa9rience contribue \xc3\xa0 votre perfectionnement professionnel.Chez ICON, notre objectif est de vous offrir une r\xc3\xa9mun\xc3\xa9ration globale compl\xc3\xa8te et concurrentielle qui comprend non seulement un excellent salaire de base, mais aussi un large \xc3\xa9ventail de programmes de r\xc3\xa9mun\xc3\xa9ration variable et de reconnaissance. De plus, nous offrons des avantages sociaux, des mesures de soutien et des initiatives de bien-\xc3\xaatre de premi\xc3\xa8re qualit\xc3\xa9, afin de vous soutenir, vous et votre famille, \xc3\xa0 toutes les \xc3\xa9tapes de votre carri\xc3\xa8re, maintenant et \xc3\xa0 lavenir.ICON, y compris ses filiales, est un employeur inclusif qui offre des chances \xc3\xa9gales et sengage \xc3\xa0 offrir un cadre de travail exempt de discrimination et de harc\xc3\xa8lement. Tous et toutes les candidat(e)s qualifi\xc3\xa9(e)s b\xc3\xa9n\xc3\xa9ficieront dune consid\xc3\xa9ration \xc3\xa9gale pour lemploi, sans distinction par rapport \xc3\xa0 la race, la couleur, la religion, le sexe, lorientation sexuelle, lidentit\xc3\xa9 de genre, lorigine nationale, le handicap ou le statut dancien combattant prot\xc3\xa9g\xc3\xa9.Si, en raison dun probl\xc3\xa8me de sant\xc3\xa9 ou dun handicap, vous avez besoin dam\xc3\xa9nagements adapt\xc3\xa9s et raisonnables pour toute partie du processus de candidature, ou pour ex\xc3\xa9cuter les fonctions essentielles dun poste, veuillez nous en informer au moyen du formulaire ci-dessous.#CRAJOB

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