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Summary

passionate about Clinical research, i have a good overall understanding of Drug Development and the Clinical Trial process. i have ability to work within team and independently. i have it skills include the use of ms office Applications, word, Excel, PowerPoint and outlook. i m seeking a new opportunity to really progress in my Career.

Experiences

Current Experience

  • Clinical Research Associate (CRA)


    Since September 2015

Past Experience

  • Clinical Research Associate (Homebased)

    October 2012 --- September 2015
    CRA responsibilities for international multicentric studies in oncology: - feasibility studies - Ethics submission - contracts Negotiation - start-up activities - monitoring

  • Clinical Research Associate (CRA)

    April 2010 --- March 2012
    follow-up of Research projects of Hospital: - involvement in writing protocols - submission of the projects to the competent authority (afssaps) and the ethic committee (cpp) - designing crf and eCRF (cleanweb) - provide logistical support for the project - setting up the study centres and monitoring - writing sops (monitoring, submission to the regulatory authorities, closing down study centres) - calculating study Budgets and drafting the Hospital contracts

  • Clinical Study Nurse (SN)

    March 2008 --- March 2010
    follow-up of 4 studies of phases i to iii for patients with blood diseases (lymphoma, multiple myeloma and chronic lymphocytic leukaemia) - execution and setting up of the internal procedures for study’s patients follow-up - Planning and organisation of patient visits (consultation & Clinical review) and monitoring visits - checking and Validation of inclusion & exclusion criteria - making the patient electrocardiograms - collecting and filling the data in the crfs/eCRF - resolving of queries - notification of Adverse Events to the sponsors - Communication with the CRA sponsor

  • Laboratory Technician

    February 2007 --- August 2007

Personality

Self Assessment :
AdaptabilityAnalytical thinkingAuthenticityIndependenceOptimismSociabilityCommunicative

Knowledge

LinkedIn Assessment :
Oncology Clinical ResearchComputer skillsWord, Power point, Excel, sphinx, Spss, Cleanweb, ORIAMGCPRegulatory submissionsLaboratory SkillsQuality AssuranceHematologyStudy MonitoringFeasibility StudiesSite InitiationeCRFCRF designProcedure CreationContract negotiation

Skills and Expertise

Self Assessment :
Assess site feasibilityConduct site initiationSelect sitesConduct monitor visitsNegotiate budget Ethics committee submissions Design case record forms Create SOPsAssist study siteAttend investigator meetingCollaborate with principal investigatorSite management

Education

  • MASTER’S DEGREE in Clinical research from Institut lilloise d’ingénierie et de management de la santé in 2012
  • LABORATORY TECHNICIAN in Clinical/Medical Laboratory Technician from Institut de formation de techniciens supérieurs in 2006

Training and Certification

  • GCP in 2015 Training
  • Languages

    BrightOwl Assessment:
    Self Assessment:
    English
    Professional Proficiency
    French
    Native
    Kinyarwanda
    Native

Area / Region

France

Others

Driving License
  • Yes

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