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Fayrouz EL OTMANI

VILLEJUIF

En résumé

Currently looking for a full-time position within a CRO or pharmaceutical company (willing to relocate outside the EU) - starting ASAP

Entreprises

  • CHU Besançon - Clinical Research Associate in Oncology

    2012 - 2013  Managing 6 industrial trials (Phase I - III) and 7 institutional trials (Phase I and II) in accordance with ICH-GCP guidelines and protocol - Support for the CRAs team in more than 15 studies (breast, urological cancers, etc.) - Managing pharmacokinetic studies
     Data entry into EDC systems (Inform, RAVE, Datatrak, Capture System)
     Resolution of data queries
     Randomization & treatment allocation using IVRS/IWRS (Almac, Bracket, Clinphone, Mdsol, Tenalea)
     Inventory of study material (lab kits, patient diary cards/questionnaires) and drug supplies in collaboration with the pharmacist
     Two trainings by CRA monitors on IMP management : drug accountability (delivery, return, comparison with IXRS…), verification of storage, transport (temperature curves), return/destruction records and maintaining Pharmacy Site File (reference on request)
     Maintaining the Investigator Site File: filing of visit reports, correspondence, essential documents as requested by monitors - Filling out forms such as Subject Screening Log, Enrolment Log, SAE Reports, etc.
     AE/SAE Reporting (FUP until resolution) according to the protocol and ICH-GCP guidelines
     Participation in pre-study activities (administrative and regulatory documents collection and tracking ; financial agreements negotiations ; budget assessment (overcosts grid))
     Training clinical research team (investigators, nurses..) on protocols and GCP
     Organization and coordination of meetings (internal team meetings, Sponsor Face-to-Face meeting)
     Organization and participation in sponsor’s international audit
     Tracking of investigator fee payments for studies - as requested by the PI (creating tracking spreadsheet to verify the consistency between subjects visits and payment details)
     Archiving study documentation
    Missions on trials promoted by the Besançon Hospital :
     Writing protocol (English synopsis included, flow chart, etc.)
     Design of paper CRFs and participation in creating an eCRF (Capture System) on colorectal cancer (including a part on medico-economic evaluation for the management of cancer)
     Coordination of an interventional trial (4 sites) : Managing centralized randomization - Biological samples tracking – Creating spreadsheets to synthesize all AE/SAEs for the Annual Safety Report
    Management – Quality Assurance in Clinical Research:
     Identification of non-compliances in conducting clinical trials towards the quality reference framework, GCPs with a prior analysis of operational and functional processes - Planning and implementation of corrective actions (specific quality tools like procedures, checklists, operational methods, etc.)
    Results: Improvement of the functioning and organization of the clinical research in the Oncology Department. Prospective and exhaustive data collection specific to the protocol in the source documents, which allows a complete and accurate filling in the trial documents (CRF, SAE Reports…)
     Writing the 1st Manual of Standard Operating Procedures (SOP) specific to the Oncology Clinical Research – 29 procedures from pre-selection to close-out (report available upon request)
     Communication : dissemination of procedures ; raising awareness all actors involved in oncology clinical research about implementing SOPs and a continuous quality improvement initiative
     Mentoring and training new Clinical Research Associates

  • INSERM ( Nantes ) - Stagiaire

    2010 - 2010 Etude des effets de l’Ezetimibe sur le transport inverse du cholestérol

Formations

  • Mediaxe Formation MEDI-AXE (Malakoff)

    Malakoff 2012 - 2012 Certificat d'Attaché de Recherche Clinique

    - Connaissances de l’environnement réglementaire (BPC - ICH) et du déroulement d’un essai clinique.
    - Mises en situation des visites de sélection, mise en place, monitoring des essais cliniques
    - Présentation d’un protocole de recherche (oncologie)
    - Conception de documents indispensables à la gestion des essais cliniques (CRF, newsletter, tableaux de suivi) - Maîtrise de la pharmacovigilance

  • Faculté Des Sciences Et Techniques De Nan (Nantes)

    Nantes 2009 - 2011 Spécialité Nutrition Humaine

    Master Recherche Biologie Santé - Sciences de l'Aliment et de la Nutrition Humaine - Mention Bien

  • Faculté Des Sciences Et Techniques De Nantes

    Nantes 2005 - 2009 Licende de Biologie Moléculaire - Biochimie

Réseau

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