ICON plc is a world-leading healthcare intelligence and clinical research organization. Were 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 worlds largest & most comprehensive clinical research organization, powered by healthcare intelligence. En tant quARC (Associ(e) de recherche clinique), vous rejoindrez la plus grande et la plus complte organisation de recherche clinique au monde, propulse par lintelligence en sant. 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 Excellence oprationnelle Contribuer aux objectifs du promoteur. Promouvoir lexcellence oprationnelle et scientifique. Identifier les opportunits et les meilleures pratiques avec les partenaires locaux/rgionaux qui contribueront lefficacit oprationnelle globale. Gestion des sites dessais cliniques Effectuer des visites de sites dessais cliniques : incluant lvaluation, linitiation, la surveillance et la clture. 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 jour des systmes de gestion lectroniques. Gestion proactive des sites, incluant : tablir et maintenir des relations solides et professionnelles avec le personnel du site. Faciliter lenrlement des sujets en intgrant des stratgies de recrutement et des plans daction au niveau du site. Maintenir la prparation laudit/inspection du site. Assurer la dclaration approprie des vnements indsirables et lutilisation des systmes de dclaration/valuation en ligne tels quIntralinks. Vrifier les donnes des formulaires lectroniques de rapport de cas (eCRF) par rapport la documentation source crite et lectronique, conformment au schma de ltude/plan de surveillance. Rpondre aux questions du site et escalader les problmes conformment aux processus et dlais. Effectuer la responsabilit et la rconciliation des produits de lessai (IP). Faciliter la mise en uvre de nouvelles technologies et systmes sur les sites cliniques (Collecte de donnes lectronique, dclaration eSAE). Maintenir les fournitures dtude 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 Bachelors 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 drivers 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) Diplme universitaire en sciences de la vie ou en soins infirmiers (quivalent dun BA/BS/BSc). Certification dinfirmier(re) autoris(e) (RN) ou qualification acadmique/ professionnelle quivalente. Exprience pralable en surveillance clinique sur site, gnralement de 1 2 ans. Connaissance approfondie des Bonnes Pratiques Cliniques (BPC/ICH-GCP) et des rglementations locales. Comptences en communication orale et crite en anglais, avec une matrise des termes mdicaux.
Job Title
CRA II (Ontario)