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Summary

as a CRA i have a great experience of Clinical trials on site, and i also acquired a significative experience in regulatory submissions and contract negociations. 

i am looking for a position of clinical regulatory specialist or Clinical Trial lead to take advantage of this experience. 

Experiences

Current Experience

  • Clinical Research Associate (CRA)

    Paris, France
    Since June 2014
    • management of Clinical sites (selection, initation, monitoring and termination visits)
    • visits for preparation of FDA submission
    • booster visits in collaboration with sponsor
    • participation in Investigator meeting
    • mentoring of junior CRA and cma
    • Management of clinical sites (selection, initation, monitoring and termination visits)
    • Visits for preparation of FDA submission
    • Booster visits in collaboration with sponsor
    • Participation in investigator meeting
    • Mentoring of junior CRA and CMA

Past Experience

  • Clinical Research Associate/Local Clinical Trial Manager Paris, France

    January 2013 --- May 2014
    • initiation and monitoring of Clinical trials on site - writing of reports (visits, telephone monitoring...)
    • contact with investigators, sponsors, authorities and project leaders
    • submission to and Communication with regulatory authorities and Ethics comittee, in france and belgium
    • feasability studies and identification of key opinion leaders
    • Negotiation, adaptation, Translation and submission of clinical contracts
    • edition of overhead grid and evaluation of Investigator fees, in collaboration with sites and sponsor
    • mentoring and management of CRA Trainee

  • Researcher PHD Student

    October 2008 --- April 2012

Personality

Self Assessment :
AdaptabilityCommunicativeAnalytical thinkingCoordinationCuriosityFlexibilityInterest in knowledgeOrganizationProblem solvingSociabilityTrust

Knowledge

Self Assessment :
Clinical monitoringClinical operationsClinical researchClinical Development Scientific writingProject Managementpeople management
LinkedIn Assessment :
LifesciencesPharmaceutical Industrymolecular biologyBiotechnologyClinical trialsClinical researchClinical monitoringResearchData AnalysisMicrosoft OfficeMicrosoft ExcelDCROBonnes pratiques cliniquesOncologieSOPCIHAffaires r

Education

  • Professional certificate in Clinical Research Associate from Institut Leonard de Vinci in 2013
  • Research Doctorate in Marine Biology and Biological Oceanography from Université de Caen Basse Normandie in 2012
  • Master's degree in Biology/Biological Sciences, General from Université Pierre et Marie Curie (Paris VI) in 2008

Languages

BrightOwl Assessment:
Self Assessment:
French
Native
English
Full Proficiency
German
Elementary Proficiency

Area / Region

Paris, France

Others

Driving License
  • Yes

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