Clinical Research Associate, (Bilingual), Remote
Sr. CRA/CRA 2 - Montreal, Remote 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 Job Advert Posting As a CRA you will be joining the worlds largest & most comprehensive clinical research organization, powered by healthcare intelligence. En tant quARC (Associe(e) de recherche clinique), vous rejoindrez la plus grande et la plus complete organisation de recherche clinique au monde, propulsee par lintelligence en sante. 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 operationnelle
- Contribuer aux objectifs du promoteur.
- Promouvoir lexcellence operationnelle et scientifique.
- Identifier les opportunites et les meilleures pratiques avec les partenaires locaux/regionaux qui contribueront a lefficacite operationnelle globale.
- Gestion des sites dessais cliniques
- Effectuer des visites de sites dessais cliniques : incluant levaluation, linitiation, la surveillance et la cloture.
- 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 a jour des systemes de gestion electroniques.
- Gestion proactive des sites, incluant :
- Etablir et maintenir des relations solides et professionnelles avec le personnel du site.
- Faciliter lenrolement des sujets en integrant des strategies de recrutement et des plans daction au niveau du site.
- Maintenir la preparation a laudit/inspection du site.
- Assurer la declaration appropriee des evenements indesirables et lutilisation des systemes de declaration/evaluation en ligne tels quIntralinks.
- Verifier les donnees des formulaires electroniques de rapport de cas (eCRF) par rapport a la documentation source ecrite et electronique, conformement au schema de letude/plan de surveillance.
- Repondre aux questions du site et escalader les problemes conformement aux processus et delais.
- Effectuer la responsabilite et la reconciliation des produits de lessai (IP).
- Faciliter la mise en uvre de nouvelles technologies et systemes sur les sites cliniques (Collecte de donnees electronique, declaration eSAE).
- Maintenir les fournitures detude 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.
- 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 (preferre
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