Clinical Research Associate- Ontario
- Toronto
- Clinical Monitoring
- ICON Strategic Solutions
- Remote
TA Business Partner
- Icon Strategic Solutions
About the role
As a CRA you will be joining the world’s largest & most comprehensive clinical research organization, powered by healthcare intelligence.
En tant qu’ARC (Associé(e) de recherche clinique), vous rejoindrez la plus grande et la plus complète organisation de recherche clinique au monde, propulsée par l’intelligence en santé.
What you will be doing:
- Conduct clinical trial site visits including evaluation, initiation, monitoring and close out
- Oversee and report on the conduct of clinical trials at a site level including and on-line site visit reports and updates to electronic management systems
- Proactive site management including:
- Building and maintaining solid and professional relationships with site staff
- Facilitating subject enrolment incorporating recruitment strategies and action plans at site level
- Maintaining site audit/inspection readiness
- Ensuring appropriate safety reporting and use of on-line safety reporting/reviewing systems such as Intralinks
- Verification of electronic case report form data against written and electronic source documentation as per study schema/monitoring plan
- Responding to site queries and escalating issues in accordance with processes and timelines
- Conducting IP accountability and reconciliation
- Facilitating implementation of new technologies and systems at clinical sites (Electronic Data Capture, eSAE reporting)
- Maintenance of site study supplies
Operational Excellence:
- Contribute to sponsor goals
- Promote operational and scientific excellence
- Identify opportunities and best practices with local/regional partners that will contribute to the overall operational effectiveness.
Gestion des sites d’essais cliniques
Effectuer des visites de sites d’essais cliniques : incluant l’évaluation, l’initiation, la surveillance et la clôture.
Superviser et rendre compte de la conduite des essais cliniques : au niveau du site, y compris les rapports de visites en ligne et les mises à jour des systèmes de gestion électroniques.
Gestion proactive des sites, incluant :
Établir et maintenir des relations solides et professionnelles avec le personnel du site.
Faciliter l’enrôlement des sujets en intégrant des stratégies de recrutement et des plans d’action au niveau du site.
Maintenir la préparation à l’audit/inspection du site.
Assurer la déclaration appropriée des événements indésirables et l’utilisation des systèmes de déclaration/évaluation en ligne tels qu’Intralinks.
Vérifier les données des formulaires électroniques de rapport de cas (eCRF) par rapport à la documentation source écrite et électronique, conformément au schéma de l’étude/plan de surveillance.
Répondre aux questions du site et escalader les problèmes conformément aux processus et délais.
Effectuer la responsabilité et la réconciliation des produits de l’essai (IP).
Faciliter la mise en œuvre de nouvelles technologies et systèmes sur les sites cliniques (Collecte de données électronique, déclaration eSAE).
Maintenir les fournitures d’étude du site.
Excellence opérationnelle
Contribuer aux objectifs du promoteur.
Promouvoir l’excellence opérationnelle et scientifique.
Identifier les opportunités et les meilleures pratiques avec les partenaires locaux/régionaux qui contribueront à l’efficacité opérationnelle globale.
You are:
- BA/BS/BSc in the sciences or nursing equivalent
- A trained CRA with on-site monitoring experience
- Comprehensive knowledge and understanding of ICH-GCP
- Fluent oral (face to face and telephone) and written English language skills
- Able and willing to travel up to 60% of the time or as per local requirements
- Possession of a full driver’s license
- Able and willing to work from a designated and appropriate home office as per local requirements
- Willing to attend and contribute to team meetings including mandatory training (remote/off-site)
- Competent computer skills including working knowledge of common software packages
- Working knowledge of trial management databases and on-line systems
- Able to attend a 1 week face to face in-house training course as part of on-boarding training
- Able and willing to work on several protocols/therapy areas
- Experience in phase II and phase III trials (preferred)
- Working knowledge of Electronic Data Capture (preferred)
Experience/working knowledge of the oncology disease area (preferred)
- Experience of Centralized/Risk Based/Targeted monitoring (preferred)
- Experience of working within a metric based environment (preferred)
Diplôme universitaire en sciences de la vie ou en soins infirmiers (équivalent d'un BA/BS/BSc).
Certification d'infirmier(ère) autorisé(e) (RN) ou qualification académique/ professionnelle équivalente.
Expérience préalable en surveillance clinique sur site, généralement de 1 à 2 ans.
Connaissance approfondie des Bonnes Pratiques Cliniques (BPC/ICH-GCP) et des réglementations locales.
Compétences en communication orale et écrite en anglais, avec une maîtrise des termes médicaux.
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Learn more about Our Culture at ICON
Day in the life

Teaser label
Our PeopleContent type
BlogsPublish date
08/29/2023
Summary
To excel as a Clinical Research Associate (CRA) in a Clinical Research Organization (CRO), you need a combination of education, skills, and the right mindset. Brazil-based CRA II Debora shares her

Teaser label
Our PeopleContent type
BlogsPublish date
05/23/2023
Summary
How to progress as a Clinical Research AssociateTo thrive as a Clinical Research Associate (CRA), it is imperative to cultivate a multifaceted skill set and demonstrate unwavering commitment to excell

Teaser label
A Day In The LifeContent type
BlogsPublish date
04/05/2023
Summary
Senior Clinical Research Associate Suzaita Hipolito talks about the satisfaction gained from working in Clinical Research. “What would it look like to wake up every day feeling happy and fulfilled?
by
Suzaita Hipolito
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