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Dhekra CHAOUACHI

LES BERGES DU LAC

En résumé

Mes compétences :
Biologie
Biotechnologies
Agriculture biologique
Informatique
Recherche clinique
Essais cliniques

Entreprises

  • MCT CRO - CRA II

    2013 - maintenant Monitoring
    Regulatory
    Filling
    Site Management
    Queries resolution
    Tracking
    IMP Management
    Payment

  • MCT CRO - Clinical Trial Assistant

    2012 - 2013 * Filing: Maintain study files, perform regular documented review and reconciliation, ensure updating of centre’s files and general files, handle all logistical aspects of a clinical trial
    * Site Management: Manage relationship with sites, Follow-up studies by phone: administrative management of sites and patients, Administrative management of investigators contracts, Assist in the coordination between the local depots, local couriers and sites, provide support to sites
    * Co-Monitoring: Participate on initiation visits of Oncology study Phase II and co-monitoring visits of diabetic study phase III, Oncology study Phase II and Relapsing Multiple Sclerosis Phase III
    * Regulatory: Collect regulatory and administrative documents for the creation and submission of regulatory dossier to EC and MoH, prepare Import License application
    * Payment: Issue invoices for investigators
    * Audit: Participate to site investigators audits and system audits
    * Tracking: Completion of study trackers
    * Investigational Medical Product: Accountability of IMP, dealing with customs broker, follow on IP accountability, return & destruction
    * Feasibility: Selection of investigators, data and essential documents collection: Phase III Hepatocellular Carcinoma study and Natural History study
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Formations

  • Faculté Des Sciences De Tunis (Tunis)

    Tunis 2008 - 2011 Master de recherche


    * Culture cellulaire et fongique
    * Analyse statistique
    * Etude génétique

  • Faculté Des Sciences De Tunis (Tunis)

    Tunis 2006 - 2008 Maîtrise

  • Institut Supérieur Des Sciences Biologiques Appliquées (ISSBAT) (Tunis)

    Tunis 2003 - 2006 DUT

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