Job Description

Overview
As a CRA you will be joining the worldxe2x80x99s largest & most comprehensive clinical research organization, powered by healthcare intelligence.
En tant quxe2x80x99ARC (Associxc3xa9(e) de recherche clinique), vous rejoindrez la plus grande et la plus complxc3xa8te organisation de recherche clinique au monde, propulsxc3xa9e par lxe2x80x99intelligence en santxc3xa9.
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 dxe2x80x99essais cliniques
Effectuer des visites de sites dxe2x80x99essais cliniques : incluant lxe2x80x99xc3xa9valuation, lxe2x80x99initiation, la surveillance et la clxc3xb4ture.
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 xc3xa0 jour des systxc3xa8mes de gestion xc3xa9lectroniques.
Gestion proactive des sites, incluant :
xc3x89tablir et maintenir des relations solides et professionnelles avec le personnel du site.
Faciliter lxe2x80x99enrxc3xb4lement des sujets en intxc3xa9grant des stratxc3xa9gies de recrutement et des plans dxe2x80x99action au niveau du site.
Maintenir la prxc3xa9paration xc3xa0 lxe2x80x99audit/inspection du site.
Assurer la dxc3xa9claration approprixc3xa9e des xc3xa9vxc3xa9nements indxc3xa9sirables et lxe2x80x99utilisation des systxc3xa8mes de dxc3xa9claration/xc3xa9valuation en ligne tels quxe2x80x99Intralinks.
Vxc3xa9rifier les donnxc3xa9es des formulaires xc3xa9lectroniques de rapport de cas (eCRF) par rapport xc3xa0 la documentation source xc3xa9crite et xc3xa9lectronique, conformxc3xa9ment au schxc3xa9ma de lxe2x80x99xc3xa9tude/plan de surveillance.
Rxc3xa9pondre aux questions du site et escalader les problxc3xa8mes conformxc3xa9ment aux processus et dxc3xa9lais.
Effectuer la responsabilitxc3xa9 et la rxc3xa9conciliation des produits de lxe2x80x99essai (IP).
Faciliter la mise en xc5x93uvre de nouvelles technologies et systxc3xa8mes sur les sites cliniques (Collecte de donnxc3xa9es xc3xa9lectronique, dxc3xa9claration eSAE).
Maintenir les fournitures dxe2x80x99xc3xa9tude du site.
Excellence opxc3xa9rationnelle
Contribuer aux objectifs du promoteur.
Promouvoir lxe2x80x99excellence opxc3xa9rationnelle et scientifique.
Identifier les opportunitxc3xa9s et les meilleures pratiques avec les partenaires locaux/rxc3xa9gionaux qui contribueront xc3xa0 lxe2x80x99efficacitxc3xa9 opxc3xa9rationnelle 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 driverxe2x80x99s 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)

Diplxc3xb4me universitaire en sciences de la vie ou en soins infirmiers (xc3xa9quivalent d'un BA/BS/BSc).
Certification d'infirmier(xc3xa8re) autorisxc3xa9(e) (RN) ou qualification acadxc3xa9mique/ professionnelle xc3xa9quivalente.
Expxc3xa9rience prxc3xa9alable en surveillance clinique sur site, gxc3xa9nxc3xa9ralement de 1 xc3xa0 2 ans.
Connaissance approfondie des Bonnes Pratiques Cliniques (BPC/ICH-GCP) et des rxc3xa9glementations locales.
Compxc3xa9tences en communication orale et xc3xa9crite en anglais, avec une maxc3xaetrise des termes mxc3xa9dicaux. '