Clinical Research Associate II

Clinical Research Associate, Ontario, Canada Remote

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 (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.

Your profile

• Bachelor's degree in a scientific or healthcare-related field.

• Minimum of 2 years of experience as a Clinical Research Associate.

• In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.

• Strong organizational and communication skills, with attention to detail.

• 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.

What ICON can offer you:

Visit our careers site 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.

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