Job Description

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 (Associe(e) de recherche clinique), vous rejoindrez la plus grande et la plus complete organisation de recherche clinique au monde, propulsee par l'intelligence en sante.
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.

Responsabilites: * Contribuer a l'identification de nouveaux centres pour des etudes cliniques

• Assumer un role d'ambassadeur pour faciliter les communications entre les centres d'etude et le Directeur de l'experience patient du promoteur, afin de rehausser la proposition de valeur aux chercheurs.
• Faciliter la preparation et la collecte des documents aux centres d'etude et a l'echelle du pays pendant toutes les phases d'etude. Soutenir le travail du gestionnaire de l'etude clinique pour la surveillance des fichiers maitres de l'etude (FME) aux centres d'etude et a l'echelle du pays. Pendant toutes les phases d'etude, s'assurer que l'archivage est conforme aux procedures d'exploitation normalisees.
• Effectuer l'initiation des centres d'etude et la formation du personnel, rediger le rapport de la visite d'initiation.
• Mettre en place la structure complete de gestion des centres d'etude, entre autres, les visites de surveillance, les evaluations reglementaires, la gestion de l'approvisionnement en medicaments, pour assurer la conformite au protocole, aux BPC, aux reglementations mondiales et locales, et aux processus mondiaux et locaux.
• Identifier les problemes aux centres d'etude; resoudre les problemes et les communiquer a un palier superieur de la direction, le cas echeant.
• Effectuer la redaction complete et la distribution des rapports sur les visites de surveillance, conformement aux procedures d'exploitation normalisees pertinentes.
• Examiner et gerer continuellement les donnees recueillies aux centres d'etude, afin de resoudre rapidement les problemes techniques et de contenu pour atteindre les cibles de verrouillage de la base de donnees en temps opportun.
• Mettre en oeuvre les activites de cloture des centres d'etude et rediger le rapport de cloture des centres d'etude.
• Fournir des commentaires sur les performances des centres d'etude afin d'evaluer leur candidature pour de futures etudes 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

Competences

• Baccalaureat ou diplome superieur en sciences de la vie ou un equivalent
• Minimum de 2 a 4 ans d'experience en surveillance de centres d'etude pour une entreprise de recherche contractuelle ou une societe pharmaceutique
• Des connaissances et une comprehension approfondies des bonnes pratiques cliniques elaborees par la Conference internationale sur l'harmonisation (BPC-CIH)
• Bilinguisme francais/anglais (maitrise verbale et ecrite) exige
• Dispose(e) et apte a voyager jusqu'a 60 % du temps a l'echelle regionale (centres d'etude a Quebec et a Montreal)
• Dispose(e) et apte a travailler sur plusieurs protocoles/domaines therapeutiques
• Experience dans les etudes cliniques de phase I a IV
• Connaissance pratique de la saisie electronique des donnees (preferable)
• Experience/connaissance pratique dans le domaine des maladies oncologiques (preferable, mais non requise)
• Experience dans la surveillance centralisee/axee sur les risques/ciblee (preferable)
• Experience de travail dans un environnement metrique (preferable)
• Souci du detail
• Competences organisationnelles et de gestion du temps de haut niveau
• Determine(e) a fournir les livrables et atteindre les objectifs des etudes
• Flexible et dispose(e) a s'adapter aux changements dans les priorites/echeanciers

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 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 .
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 to apply

Skills Required