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CRA II

  1. Burlington
JR120137
  1. Clinical Monitoring
  2. ICON Full Service & Corporate Support
  3. Hybrid: Office/Remote

About the role

This vacancy has now expired. Please see similar roles below...

Requirements:

  • 12+ months of monitoring experience as a CRA for a sponsor or CRO
  • Must be both French and English speaking
  • Located in either Quebec or Ontario Canada

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

As a Clinical Research Associate at ICON, you’ll work within a large-scale, fast-paced environment alongside a close-knit team of highly qualified CRAs to identify, select, initiate and close-out investigational sites for clinical studies in phases II – IV, ensuring adherence to applicable regulations and principles of ICH-GCP.

The role:
• Independent, proactive work to set up and monitor studies, complete reports and maintain documentation
• Submitting protocol, consent documents for ethics/IRB approval, as well as preparing regulatory submissions
• Balancing sponsor generated queries
• Taking responsibility for study cost efficiency
• Preparation and review of study documentation and feasibility studies for new proposals
• Potential to assist in training and mentoring fellow CRAs

You will need:
• 12 months+ of monitoring experience in phase I-III trials as a CRA
• College degree in medicine, science, or equivalent
• Previous monitoring experience in medium-sized studies, including study start-up and close-out
• Knowledge of ICH-GCP guidelines and ability to review and evaluate medical data
• Excellent written and verbal communication
• Ability to work to tight deadlines
• Availability to travel least 60% of the time (international and domestic -fly and drive) and should possess a valid driving license

Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON 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 through the form below.

ICON plc est un chef de file mondial en matière de soins de santé intelligents et de recherches cliniques. De la molécule au médicament, nous faisons progresser la recherche clinique en fournissant des services externalisés à des entreprises pharmaceutiques, biotechnologiques, de fabrication de dispositifs médicaux ainsi qu’à des organismes gouvernementaux et de santé publique.
Les patients étant au cœur de tout ce que nous faisons, nous contribuons à accélérer le développement de médicaments et de dispositifs qui sauve des vies et améliore la qualité de vie.
Nos employés constituent notre principal atout, ils sont l’essence de notre culture et le moteur de notre réussite. Les employés de ICON ont pour mission de réussir et sont passionnés, ce qui fait en sorte que ce que nous faisons, nous le faisons bien.


Poste – Assistant(e) de recherche clinique II
• Travailler de façon indépendante et proactive pour coordonner toutes les activités
nécessaires à la mise en place et à la surveillance d’une étude, remplir les rapports
d’étape de manière exacte et tenir à jour la documentation liée à l’étude
• Soumettre des protocoles, des documents de consentement pour approbation
auprès des comités d’éthiques/comités d’éthique indépendants et aider à la
préparation de demandes auprès des autorités réglementaires comme demandé
• Participer à la préparation et à la révision de la documentation relative à l’étude et
aux études de faisabilité pour les nouvelles propositions au besoin
• Gérer les demandes provenant du promoteur de manière efficace et être
responsable du rapport coût-efficacité de l’étude
• En fonction de votre niveau d’expérience, vous pourriez aider à la formation et au mentorat d’ARC moins expérimentés et/ou gérer des ARC qui travaillent sur des projets internationaux


Exigences
• Minimum de 18 mois d’expérience indépendante et active en surveillance sur le
terrain – tous les types de visites.
• Connaissance des lignes directrices ICH GCP et expertise pour examiner et évaluer
des données médicales
• Excellentes habiletés en communication et en relations interpersonnelles, tant à
l’écrit qu’à l’oral, vous permettant de gérer les demandes en temps opportun
• Capacité à produire un travail rigoureux dans des délais serrés et un environnement exigeant Pourquoi vous joindre à nous?
Le développement continu est vital chez nous, et en tant qu’ARC I vous aurez l’occasion de progresser dans votre carrière avec la possibilité de travailler dans d’autres domaines reliés afin d’élargir votre gamme de compétences. Nos avantages sociaux sont concurrentiels, notre envergure est internationale et nous nous soucions sincèrement de nos employés et de leur réussite.
Avantages à travailler chez ICON

Notre réussite est tributaire de la connaissance, des capacités et de la qualité de nos employés. C’est la raison pour laquelle nous sommes engagés envers le perfectionnement de nos employés dans le cadre d’une culture d’apprentissage continue. Une culture où vous êtes stimulé(e) par un travail épanouissant et où chaque expérience contribue à votre perfectionnement professionnel.

Chez ICON, nous mettons l’accent à vous offrir une rémunération globale concurrentielle qui n’inclut pas uniquement un excellent niveau salarial de base, mais aussi un vaste éventail de programmes de paye variable et de programmes de reconnaissance. De plus, nos avantages sociaux, politiques de soutien et initiatives relatives au mieux-être de catégorie supérieure
sont conçus pour répondre à vos besoins et à ceux de votre famille à toutes les étapes de votre carrière, dès aujourd’hui et dans l’avenir.
ICON, ainsi que ses filiales, est un employeur inclusif, souscrivant au principe de l’égalité d’accès à l’emploi et s’engage à offrir un milieu de travail sans discrimination et harcèlement. Tous les candidats qualifiés seront pris en considération de manière égale et sans égard 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.

Si, en raison d’un problème médical ou d’un handicap, vous avez besoin d’un
accommodement raisonnable pour une partie quelconque du processus de candidature, ou afin d’accomplir les tâches essentielles d’un poste, veuillez nous le faire savoir en remplissant le formulaire ci-dessous.

#LI-SW3

List #1

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