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Laurence AGEZ

COLMAR

En résumé

CRA competences :

• Selection, Initiation, Monitoring, Close-out visits
• Participation in investigators meetings (national and international)
• eCRF training
• Interaction with international team (Data Management, laboratories, project managers, local CRA)
• Management of treatment (accountability review, return and destruction organization)
• Training to the local procedures
• Coordination (teleconference organization, monitoring reports review)
• Word, Excel, Power Point
• English (intermediate), French (mother tongue)

Mes compétences :
Monitoring
Essais cliniques
Neurosciences
Bonnes pratiques cliniques
Recherche clinique

Entreprises

  • INC research - ARC

    2015 - maintenant

  • Medpace - Clinical Research Associate

    2012 - 2014 * Conduct pre-study(feasibility and qualification visit), initiation, monitoring, and close-out visits according to SOPs and GCP

    * Responsible for overall site management for assigned sites including written and verbal communication and scheduling of monitoring visits

    * Responsible for completion of visit reports and maintenance of study-related databases ;
    * May serve as Lead CRA on a project, acting as the primary contact for all monitoring-related questions for the monitoring team

    * Act as resource and facilitate training for new CRAs ;
    * Performed treatment management such as accountability review and return and destruction organization

    Clinical Research Projects
    * Phase III / International study / Non-24-hour-sleep-wake disorder / 5 national sites / 40 patients ;
    * 3 Phase III / International study / Hypercholesterolemia / 5 national sites / 20 patients ;
    * 2 Phase III / International study / Severe triglyceridemia / 5 national sites / 20 patients ;
    * Phase III / Internationnal Study/ Oncology/ qualification visit 7 national sites ;

  • Forenap Pharma - On site Clinical Research Associate

    2008 - 2012 * Conducted initiation, monitoring, and close-out visits for protocol phase 1, 3 and 4 ;
    * Participated in Investigators meetings ;
    * Trained personnel on eCRFs, IVRS/IWRS call
    * Interacted with international team ;
    * Trained personnel on local procedures ;

  • Forenap - ARC

    2008 - 2012

  • IRSN - Post-doctorat

    Fontenay-aux-Roses 2007 - 2008

Formations

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