Clinical Research Associate I/II

2 weeks ago

Montreal, Quebec, Canada ICON 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 4ans 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 phaseI 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 knowledge, capabilities and quality of our people. That's 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 succès dépend des connaissances, des capacités et de la qualité de notre personnel. C'est pourquoi nous nous engageons à former nos employé(e)s dans une culture d'apprentissage continu — une culture où nous vous mettons au défi de faire du travail intéressant et où chaque expérience contribue à votre perfectionnement professionnel.

Chez ICON, notre objectif est de vous offrir une rémunération globale complète et concurrentielle qui comprend non seulement un excellent salaire de base, mais aussi un large éventail de programmes de rémunération variable et de reconnaissance. De plus, nous offrons des avantages sociaux, des mesures de soutien et des initiatives de bien-être de première qualité, afin de vous soutenir, vous et votre famille, à toutes les étapes de votre carrière, maintenant et à l'avenir. ICON, y compris ses filiales, est un employeur inclusif qui offre des chances égales et s'engage à offrir un cadre de travail exempt de discrimination et de harcèlement. Tous et toutes les candidat(e)s qualifié(e)s bénéficieront d'une considération égale pour l'emploi, sans distinction par rapport à la race, la couleur, la religion, le sexe, l'orientation sexuelle, l'identité de genre, l'origine nationale, le handicap ou le statut d'ancien combattant protégé. Si, en raison d'un problème de santé ou d'un handicap, vous avez besoin d'aménagements adaptés et raisonnables pour toute partie du processus de candidature, ou pour exécuter les fonctions essentielles d'un poste, veuillez nous en informer au moyen du formulaire ci-dessous.

#CRAJOB

#J-18808-Ljbffr

  • Clinical Research Associate I/ii

    2 weeks ago

    Montreal, Quebec, Canada ICON plc Full time

    As a **Clinical Research Associate I or II,** you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.**Responsibilities**:- Contribute to the identification of new sites for clinical trials- Assume ambassadorial role to facilitate communication between sites and sponsor CPO to increase...

  • Regulatory Affairs Assistant

    2 weeks ago

    Montreal, Quebec, Canada Innovaderm Research Full time

    The Regulatory Affairs Assistant is responsible for handling regulatory documents and maintaining the Investigator's Study Files (ISFs) for all studies at the clinical research unit.RESPONSABILITIESMore specifically, the Regulatory Affairs Assistant must:Track the signatures of regulatory forms (i.e., QIU, FDA1572, financial disclosure forms) and other...

  • Assistant Clinical Research Coordinator

    2 weeks ago

    Montreal, Quebec, Canada Innovaderm Research Full time

    This role will be perfect for you if:You have some experience in clinical research and a passion for this field You enjoy working in a supportive and collaborative environment You enjoy working directly with patients**RESPONSABILITIESResearch protocols Understand all clinical research protocols for the studies in which they collaborate, explaining the...

  • Bilingual Clinical Research Associate

    2 weeks ago

    Montreal, Quebec, Canada Medpace, Inc. Full time

    Job Summary:Medpace is growing quickly and we are seeking a Clinical Research Associate to join our team in Canada. We are an innovative, scientifically oriented mid-sized CRO that is focused on full-service project work.This is a home-based position in Canada.Through our _PACE _Training Program, you will join other ***Professionals Achieving CRA Excellence...

  • Fsp - Clinical Project Manager

    2 weeks ago

    Montreal, Quebec, Canada Allphase Clinical Research Inc. Full time

    Your responsibilities include, but are not limited to: - Lead local evidence generation strategy and operations for key products/indications; Endtoend management of local study design, analysis and communication of results for local clientsponsored studies; Management of local research budget forecast, management and reconciliation; Management of operations...

  • Clinical Research Technician I

    2 weeks ago

    Montreal, Quebec, Canada Altasciences Full time

    Your New CompanyAt Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them. No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of...

  • Clinical Research Technician I

    2 weeks ago

    Montreal, Quebec, Canada Altasciences Full time

    At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them. No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee...

  • Clinical Research Coordinator

    2 weeks ago

    Montreal, Quebec, Canada Research Institute of the McGill University Health Centre Full time

    Do you want to work for a world-renowned research institute that pushes the boundaries of biomedical science and health research? Right here in Montreal At the Research Institute of the McGill University Health Centre (RI-MUHC), you can be part of an organization focused on scientific discovery and innovation in patient-centered medicine. Join us today and...

  • Clinical Research Clerk

    2 weeks ago

    Montreal, Quebec, Canada Research Institute of the McGill University Health Centre Full time

    Do you want to work for a world-renowned research institute that pushes the boundaries of biomedical science and health research? Right here in Montreal At the Research Institute of the McGill University Health Centre (RI-MUHC), you can be part of an organization focused on scientific discovery and innovation in patient-centered medicine. Join us today and...

  • Clinical Research Coordinator

    3 weeks ago

    Montreal, Quebec, Canada Research Institute of the McGill University Health Centre Full time

    Do you want to be part of a renowned research institute in Montreal that is dedicated to pushing the boundaries of biomedical science and health research? Join the Research Institute of the McGill University Health Centre (RI-MUHC) to contribute to scientific discovery and innovation in patient-centered medicine. Make an impact with us!Job...

  • Clinical Research Coordinator

    2 weeks ago

    Montreal, Quebec, Canada Centre universitaire de santé McGill Full time

    Organization descriptionLe Centre universitaire de santé McGill (CUSM) est un centre hospitalier universitaire intégré, reconnu à l'échelle internationale pour l'excellence de ses programmes cliniques, de sa recherche et de son enseignement. Le CUSM a pour objectif d'assurer aux patients des soins fondés sur les connaissances les plus avancées dans le...

  • Early Phase Project Manager Ii

    2 weeks ago

    Montreal, Quebec, Canada Syneos Health Clinical Full time

    DescriptionProject Manager IISyneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve...

  • Clinical Research Manager

    3 weeks ago

    Montreal, Quebec, Canada Parexel Full time

    PXL is seeking a Clinical Research Manager (CRM) in Canada for one of our large FSP clients This is a remote position with some travel.Oncology experience is preferred Position Purpose:The Clinical Research Manager (CRM) is responsible for the following:Primarily accountable for end-to-end performance and project management for assigned protocols in a...

  • Research Associate in Clinical Epidemiology and

    3 weeks ago

    Montreal, Quebec, Canada Centre universitaire de santé McGill Full time

    Organization descriptionLe Centre universitaire de santé McGill (CUSM) est un centre hospitalier universitaire intégré, reconnu à l'échelle internationale pour l'excellence de ses programmes cliniques, de sa recherche et de son enseignement. Le CUSM a pour objectif d'assurer aux patients des soins fondés sur les connaissances les plus avancées dans le...

  • Manager, Clinical Support

    2 weeks ago

    Montreal, Quebec, Canada Innovaderm Research Full time

    Manager, Clinical Support, Head office, Montreal, QcThe Manager, Clinical Support works in close collaboration with the Director, Clinical Research Unit and Clinical staff to manage team and offer support at the various stages of the management of Clinical Research.The manager is responsible to lead the activities and for overseeing the day-to-day management...

  • Research Assistant 1

    2 weeks ago

    Montreal, Quebec, Canada McGill University Full time

    Please refer to thejob aid for instructions on how to apply.The Research Assistant 1 assists the research team in conducting research projects and as required, is responsible for the functional supervision of the Undergraduate/Graduate students and visiting international students.Research assistant assisting in the performance of behavioral and...

  • Clinical Research Coordinator

    2 weeks ago

    Montreal, Quebec, Canada Centre universitaire de santé McGill Full time

    RESEARCH INSTITUTE OF THE MUHCThe Research Institute of the McGill University Health Centre (RI-MUHC) is a world-renowned biomedical and hospital research centre. Located in Montreal, Quebec, the Institute is the research arm of the McGill University Health Centre (MUHC) affiliated with the Faculty of Medicine at McGill University. The RI-MUHC is supported...

  • Bilingual Clinical Research Associate

    2 weeks ago

    Montreal, Quebec, Canada ICON Strategic Solutions Full time

    Overview: ICON 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...

  • Research Associate

    2 weeks ago

    Montreal, Quebec, Canada McGill University Full time

    Please refer to thejob aid for instructions on how to apply.Dr. Vincent Mooser's lab is passionate about the use of genetics and genomics to support drug discovery and development. The CERC has a mission to use cutting-edge genomics and genetics to support the discovery and development of novel therapeutics.Position Summary:Contribute to the identification...

  • Bilingual Clinical Research Associate

    2 weeks ago

    Montreal, Quebec, Canada ICON Strategic Solutions Full time

    Overview:ICON 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...