Job Description

Overview
As a CRA you will be joining the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence.
En tant qu'ARC (Associe(e) de recherche clinique), vous rejoindrez la plus grande et la plus complete organisation de recherche clinique au monde, propulsee par l'intelligence en sante.
Responsibilities
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'evaluation, l'initiation, 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 l'enrolement des sujets en integrant des strategies de recrutement et des plans d'action au niveau du site.
Maintenir la preparation a l'audit/inspection du site.
Assurer la declaration appropriee des evenements indesirables et l'utilisation des systemes de declaration/evaluation en ligne tels qu'Intralinks.
Verifier les donnees des formulaires electroniques de rapport de cas (eCRF) par rapport a la documentation source ecrite et electronique, conformement au schema de l'etude/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 l'essai (IP).
Faciliter la mise en oeuvre de nouvelles technologies et systemes sur les sites cliniques (Collecte de donnees electronique, declaration eSAE).
Maintenir les fournitures d'etude du site.
Excellence operationnelle
Contribuer aux objectifs du promoteur.
Promouvoir l'excellence operationnelle et scientifique.
Identifier les opportunites et les meilleures pratiques avec les partenaires locaux/regionaux qui contribueront a l'efficacite operationnelle globale.
Qualifications
You are:

• 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)

Diplome universitaire en sciences de la vie ou en soins infirmiers (equivalent d'un BA/BS/BSc).
Certification d'infirmier(ere) autorise(e) (RN) ou qualification academique/ professionnelle equivalente.
Experience prealable en surveillance clinique sur site, generalement de 1 a 2 ans.
Connaissance approfondie des Bonnes Pratiques Cliniques (BPC/ICH-GCP) et des reglementations locales.
Competences en communication orale et ecrite en anglais, avec une maitrise des termes medicaux.

Skills Required