Clinical Research Associate, (Bilingual), Remote

Sr. CRA/CRA 2 - Montreal, Remote reputed company 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 Job Advert Posting As a CRA you will be joining the world’s largest & most comprehensive clinical research organization, powered by healthcare intelligence. En tant qu’reputed company (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 reputed company out
• reputed company 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
• 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 reputed company 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 Å“uvre de nouvelles technologies et systèmes sur les sites cliniques (Collecte de données électronique, déclaration eSAE).
• Maintenir les fournitures d’étude du site.
• Â 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 reputed company 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-reputed company 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)
• Â Experience/working knowledge of the oncology disease area (preferred)
• Experience of Centralized/Risk Based/Targeted monitoring (preferred)
• Experience of working reputed company 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.
• reputed companyérience préalable en surveillance clinique sur site, généralement de 1 à 2 reputed company.
• 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 reputed company 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 reputed company 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 reputed company.
• Global Employee Assistance Programme, reputed company, 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 careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are reputed company to our culture and values.   We’re dedicated to providing an inclusive and accessible environment for reputed company candidates. ICON is committed to providing a workplace free of discrimination and harassment. reputed company qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national reputed company, 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 reputed company the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet reputed company of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly reputed company’re looking for here at ICON whether it is for this or other roles. Are you a reputed company ICON Employee? Please click here to apply Apply tot his job Apply To this Job