Clinical Research Associate II

3 weeks 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

  • Research Technician II

    1 week ago

    Toronto, Ontario, C6A, Ontario, Canada University Health Network Full time

    The University Health Network, where “above all else the needs of patients come first”, encompasses Toronto General Hospital, Toronto Western Hospital, Princess Margaret Cancer Centre, Toronto Rehabilitation Institute and the Michener Institute of Education. The breadth of research, the complexity of the cases treated, and the magnitude of its...

  • Senior Clinical Research Associate

    3 weeks ago

    Ontario, Canada Parexel Full time

    Parexel FSP is looking for a CRA/SrCRA in the Ontario and Quebec Area of Canada.Cell Therapy Trial experience strongly preferred.Job Purpose:The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other...

  • Senior Clinical Research Associate

    3 weeks ago

    Ontario, Canada Parexel Full time

    Parexel FSP is looking for a CRA/SrCRA in the Ontario and Quebec Area of Canada. Cell Therapy Trial experience strongly preferred. Job Purpose: The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration...

  • Senior Clinical Research Associate

    3 weeks ago

    Ontario, Canada Parexel Full time

    Parexel FSP is looking for a CRA/SrCRA in the Ontario and Quebec Area of Canada.Cell Therapy Trial experience strongly preferred.Job Purpose:The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other...

  • Research Coordinator Ii

    1 week ago

    Toronto, Ontario, Canada St. Michael's Hospital - Unity Health Toronto Full time

    The Applied Education Research Operatives (AERO) is seeking a Research Coordinator II, Casual.You will be working closely with the Research Coordinator III, and Principal Investigators on a variety of projects. This position performs research activities involving project design, collecting, summarizing or analyzing data.Tasks may include assisting in study...

  • Senior Clinical Research Associate

    1 month ago

    Ontario, Canada, Canada Parexel Full time

    Parexel FSP is looking for a CRA/SrCRA in the Ontario and Quebec Area of Canada.Cell Therapy Trial experience strongly preferred.Job Purpose:The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other...

  • Clinical Research Associate II

    3 weeks 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...

  • Research Technician II

    3 months ago

    Toronto, Ontario, C6A, Ontario, Canada University Health Network Full time

    The University Health Network, where “above all else the needs of patients come first”, encompasses Toronto General Hospital, Toronto Western Hospital, Princess Margaret Cancer Centre, Toronto Rehabilitation Institute and the Michener Institute of Education. The breadth of research, the complexity of the cases treated, and the magnitude of its...

  • Clinical SAS Programmer

    5 months ago

    Mississauga, Ontario, Peel region, Canada Pharma Medica Research Inc. Full time

    Pharma Medica Research (PMRI) is a Contract Research Organization that strives for innovation and original solutions in a highly regulated and competitive industry. We are a full service contract research organization specialized in conducting early phase clinical trials in healthy volunteers, special and patient populations. We are actively looking for...

  • Associate Medical Writer

    1 month ago

    Mississauga, Ontario, Peel region, Canada Pharma Medica Research Inc. Full time

    Pharma Medica Research (PMRI) is a Contract Research Organization that strives for innovation and original solutions in a highly regulated and competitive industry. We are a full service contract research organization specialized in conducting early phase clinical trials in healthy volunteers, special and patient populations. We are actively looking for...

  • Clinical Research Associate II

    1 month ago

    Ontario, Canada, 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 trialsAssume...

  • Research Associate

    1 month ago

    Toronto, Ontario, Ontario, Canada Avicanna Inc. Full time

    About AvicannaAvicanna is a diversified and vertically integrated Canadian biopharmaceutical company focused on the research, development, and commercialization of plant-derived cannabinoid-based products for the global consumer, medical, and pharmaceutical market segments. Avicanna is a company that is focused on quality control and excellence with many...

  • Clinical Psychologist

    1 day ago

    Hamilton, Ontario, Canada Hamilton Health Sciences Full time

    McMaster Children's Hospital (MCH) is part of the Hamilton Health Sciences' family of hospitals. MCH serves a community of 2.3 million people from south central Ontario and beyond. The Pediatric Chronic Pain Program is an ambulatory clinic of the Child and Youth Clinic. The program provides coordinated, comprehensive pediatric chronic pain services through...

  • Quality Assurance Compliance Associate

    1 month ago

    Mississauga, Ontario, Peel region, Canada Pharma Medica Research Inc. Full time

    Pharma Medica Research (PMRI) is a Contract Research Organization that strives for innovation and original solutions in a highly regulated and competitive industry. We are a full service contract research organization specialized in conducting early phase clinical trials in healthy volunteers, special and patient populations. We are actively looking for...

  • Clinical Research Study Assistant

    1 week ago

    Toronto, Ontario, C6A, Ontario, Canada Humber River Regional Hospital Full time

    Position Profile Humber River Health. Lighting New Ways In Healthcare. Since opening our doors in 2015 as North America’s first fully digital hospital, we remain unwavering in our belief that we can change the hospital where we work, the community where we live, and the world of healthcare beyond our borders. Serving a community of 850,000 residents in...

  • Clinical Educator

    1 week ago

    Toronto, Ontario, Canada St. Michael's Hospital - Unity Health Toronto Full time

    Reporting to the Senior Clinical Program Director Oncology & Endoscopy Program, the Clinical Educator - Nursing for Gastroenterology, General Surgery, Plastics and Acute Care Surgery serves as a role model and leader to support nursing care that optimizes patient outcomes and experiences while enhancing the safety, efficiency, effectiveness and accessibility...

  • Biostatistician II

    1 month ago

    Toronto, Ontario, C6A, Ontario, Canada University Health Network Full time

    The University Health Network, where “above all else the needs of patients come first”, encompasses Toronto General Hospital, Toronto Western Hospital, Princess Margaret Cancer Centre, Toronto Rehabilitation Institute and the Michener Institute of Education. The breadth of research, the complexity of the cases treated, and the magnitude of its...

  • Research Coordinator, Sunnybrook Research

    1 week ago

    Toronto, Ontario, Canada Sunnybrook Health Sciences Centre Full time

    Research Coordinator, Sunnybrook Research Institute (12082021-3) Toronto, ON, CA Posted: 12/8/2021 2:45:35 PM Research Coordinator, Sunnybrook Research Institute Employment Type: Temporary Full time, one year with possibility of renewal Hours: 37.5 hours/week (1.0 FTE) Department: Evaluative Clinical Sciences, Sunnybrook Research Institute Job Summary Dr....

  • Clinical Data Associate

    6 months ago

    Etobicoke, Ontario, Toronto, Canada SCiAN Services Full time

    SCiAN Services is a rapidly growing Contract Research Organization that has a passion to solve for unmet needs in the Biotechnology/ Pharmaceutical Industry. For over 35 years SCiAN has embraced innovation when offering services in Pharmacovigilance, Biostatistics, Data Management and Custom Database Solutions. SCiAN’s therapeutic expertise includes...

  • Senior Researcher

    3 weeks ago

    Ontario, Canada Bentham Science Full time

    We are currently seeking Editorial Board Members for "The Open Anesthesia Journal" We are seeking experienced researchers and scientists to join us as Editorial Board Members for the journal, "The Open Anesthesia Journal" . About the Role: Actively contribute to the development and growth of the journal by providing valuable scholarly input, including...