Clinical Research Associate, Sponsor Dedicated

Clinical Research Associate, Sponsor Dedicated

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

• Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.

• Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.

• Collaborating with investigators and site staff to facilitate smooth study conduct.

• Performing data review and resolution of queries to maintain high-quality clinical data.

• Contributing to the preparation and review of study documentation, including protocols and clinical study reports

• 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.

• 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.

•  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.

• 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

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.

• Ability to work independently and collaboratively in a fast-paced environment.

• Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver’s license

• 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:
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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

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.

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 here

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 here to apply