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Summary

quadrilingual (with notion of japanase) Clinical reasearh Associate

Experiences

Current Experience

  • Clinical Research Associate (CRA)

    Paris 8, Paris, France
    Since March 2016

    international CRA (france/italy/germany)

    oncology 2 studies :

    • randomized, double-blind, Phase III trial of olaparib vs. placebo in patients with advanced figo stage iiib – iv high grade serous or endometrioid ovarian, fallopian tube, or peritoneal Cancer treated with standard first-line Treatment, combining platinum-taxane chemotherapy and bevacizumab concurrent with chemotherapy and in maintenance- 12 sites in france and in italy-38 patients (site initiation-monitoring-remote monitoring)
    • Phase 3 multi-center randomized study to compare efficacy and safety of romidepsin-chop (ro-chop) vs chop in patients withpreviously untreated peripheral t-Cell lymphoma-1 site in italy-1 patient (monitoring)

    ophtalmology 2 Medical Device

    • prospective randomized Clinical Trial comparing an introcular lens with extended depth focus vs a regular monofocal intraocular lens- 3 sites in germany-40 patients (monitoring)
    • clinical investigation of a Medical Device laser system-3 sites in uk, switzerland and latvia-45 patients (monitoring-close out visits)

    International CRA (France/Italy/Germany)

    Oncology 2 studies :

    • Randomized, Double-Blind, Phase III Trial of Olaparib vs. Placebo in Patients with Advanced FIGO Stage IIIB – IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer treated with standard First-Line Treatment, Combining Platinum-Taxane Chemotherapy and Bevacizumab Concurrent with Chemotherapy and in Maintenance- 12 sites in France and in Italy-38 patients (Site Initiation-Monitoring-Remote monitoring)
    • Phase 3 Multi-center Randomized Study to compare Efficacy and safety of Romidepsin-CHOP (Ro-CHOP) vs CHOP in patients withpreviously untreated peripheral T-cell lymphoma-1 site in Italy-1 patient (Monitoring)

    Ophtalmology 2 Medical Device

    • Prospective randomized clinical trial comparing an introcular lens with extended depth focus vs a regular monofocal intraocular lens- 3 sites in Germany-40 patients (monitoring)
    • Clinical Investigation of a medical device laser system-3 sites in UK, Switzerland and Latvia-45 patients (Monitoring-Close Out visits)

Past Experience

  • Clinical Research Associate (CRA) Le Kremlin-Bicêtre, France

    June 2014 --- February 2016

    Clinical reseach association

    3 cohort in Virology-pediatric and gynecologic services with Biological collection

    • national cohort in hiv1 and/or hiv2 mother to child transmission and prevention-75 sites more than 7000 patients per year (site intitation, monitoring, remote-monitoring)
    • national cohort of infected children by hiv1 and/or hiv2 24 sites- 724 patients (monitoring, remote monitoring)
    • pathophysiological study of the immuno-virological evolution of infected children with hiv-1 perinatal according to early or late initiation of antiretroviral therapy (creation of site inititiation document and SOP)

  • Clinical Research Associate (CRA) Maisons-Laffitte, France

    September 2014 --- April 2015

    Clinical Research Associate/clinical reseach Coordinator

    3 observationnal studies in

    1 Phase III trial in Gastroenterology (gor)-140 sites-0patients (early close out)

    1 Medical Device in ophtalmology (eye dry)-40 sites-150 patients (site intitiation-monitoring)

  • Intership master degree Orléans, France

    January 2012 --- June 2012
    involvment of dsp1 Protein into "leukemia-like" tumor formation on drosophilia model : - drosophilia study model designing in order to analyze the involvement of a hematopoiesis’ Protein into "leukemia-like" solid tumors formation - study of Protein-Gene interactions in hematopoietic cells. - protocols setting-up - collecting and Analysis of datas - wrinting and presenting report to scientific committee

Personality

Self Assessment :
IndependenceCuriosityEfficiencyFlexibilityOptimismOrganizationResponsibilitySelf-confidence

Knowledge

Self Assessment :
Biochemistry Animal models Cell biology R&DAllergy and immunologyBacteriologyBioinformaticsBiotechnologyCancer ResearchCell biologyClinical monitoringCRFCRODNAeCRFELISAEndocrinology and metabolismEnglishEnzyme-linked immunosorbent assay (ELISA)EpidemiologyFACSGastroenterologyGel ElectrophoresisGeneticsGenomicsGermanGood Clinical Practice (GCP)Gynecologic oncologyGynecologyHematologyICH guidelinesImmunoassaysImmunofluorescenceImmunologyInfectious diseasesInformed Consent DocumentsIVRSLaboratory ResearchMammalian Cell CultureMedical oncology Microsoft ExcelMicrosoft OfficeMicrosoft PowerpointMicrosoft WordMolecular & Cellular BiologyMolecular geneticsNephrologyoncologyOncology Clinical ResearchOphthalmologyOutlookPatient Follow UpPCRPediatricsPhase IPhase IIPhase IIIPhysiologyqPCRRNA isolationRT-PCRSerious Adverse Event (SAE)Teamwork

Skills and Expertise

Self Assessment :
Create SOPs Interact with nurses Monitor a clinical study Report dataAdverse event reportingApprove queriesApprove monitoring reportsCollect dataComplete case report form (CRF)Data entryData verificationEnsure good clinical practice (GCP)Establish professional relationships with partnersInteract with pharmacistsMonitor dataMonitoring enrolmentReport non-compliance incidentsReport serious adverse events (SAE)Review informed consent processReview inclusion criteriaSolve problemsVerify dataWork with coordination and data management teams

Education

  • CRA professional training in Pharmacy from Mediaxe formation in 2014
  • Master in Biochemistry and Molecular Biology from University of Orlean in 2012
  • Bachelor in Biochemistry and Biotechnology from University of Orleans in 2010

Training and Certification

  • CRA in 2014 Certification

Languages

BrightOwl Assessment:
Self Assessment:
French
Native
English
Professional Proficiency
German
Elementary Proficiency
Italian
Elementary Proficiency
Japanese
Elementary Proficiency

Work Preferences

  • Positions I am interested in:
    Clinical Research Associate (CRA)
  • Positions I am NOT interested in:
    Assistant Clinical Trial Assistant (CTA) Marketing Manager
  • Locations I am interested in:
    France
  • Work From Home:
    No
  • Work Regime:
    Permanent position
  • International:
    Yes

Publications

    Expert has 1 publications (Will be avalible with full profile)

Area / Region

Paris, France

Others

Driving License
  • No

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