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As a Clinical Research Consultant, I have acquired more than 16 years’ experience in international phase II and III clinical trials, mainly as a project manager and a CRA in a Biotech Company and academic Sponsors and CROs in France. 

I have been working in multiple therapeutic areas such as infectious diseases (Hepatitis B, HIV), autoimmune diseases (Lupus, Crohn’s disease, Rheumatoid Arthritis), vaccines, and neonatology. In the past three years, I have been specifically responsible for opening an ongoing international clinical trial in the USA. My biggest asset is my strong knowledge of both European and FDA regulations. During my career, I have worked in close collaboration with Quality Assurance teams, writing SOPs, managing and reviewing CAPAs.

In 2018, I have decided to improve my knowledge in Quality Assurance and Auditing. I was certified as an Auditor by Barnett International in 2018. I have conducted a few sites and laboratory co-audits. 

I am an enthusiastic and detailed-oriented professional, with good communicative skills. I am fluent in French and English and have an advanced knowledge of Spanish and Italian. When I am not working, I love volunteering for the environmental causes, gardening and hiking.

Experiences

Current Experience

  • Senior Clinical Research Associate (CRA)

    Paris, France
    Since February 2019

Past Experience

Personality

Self Assessment :
Attention to detailCollaborationCommunicativeCritical thinkingCuriosityEfficiencyFlexibilityIndependenceInterest in knowledgeOrganizationProblem solvingSelf-confidenceTrust

Knowledge

Self Assessment :
Clinical monitoringClinical researchClinical Study DesignClinical trial audits and inspectionsClinical trial managementClinical trialsElectronic Data Capture (EDC) Good Clinical Practice (GCP)ImmunologyInfectious diseasesInformed Consent ProcessPhase IIPhase IIIPhases of clinical development (phase I to IV)Phase IVProject CoordinationProject ManagementProtocolQuality Assurance (QA)Regulatory submissionsStudy protocolsVaccinesWriting Study Procedures and SOPs

Skills and Expertise

Self Assessment :
Build and manage the Trial Master File (TMF) Create SOPs Design case record forms Develop clinical trial protocols Guide students Write protocolsBuild trial master file (TMF)Complete case report form (CRF)Conduct site initiationConduct studiescoordinating research projectsCreate clinical documentsCreate standard operating procedure (SOP)Design subject consent formFollow up projectsInformed consent processInteract with pharmacistsInteract with physiciansInteract with regulatory stakeholdersInteract with statisticiansInteract with KOLMonitor dataOrganise meetingsOrganise steering committeePersuade clinicians to conduct clinical trialsPrepare regulatory documentsPresent at steering committeeReview informed consent processReview monitoring reportsReview study protocolsReview reportsWritten presentationWriting regulatory documentsWrite documentsTrain on site staffSupervise clinical monitorsSelect investigators

Education

  • Training of investigators to clinical trials in Clinical research from University Paris VII, France in 2003
  • PostDoc in Immunology from INSERM U567, Paris, France in 2002
  • Ph.D. in Human Biology from University Lyon I, France in 1999
  • Agronomy Engineer in Agronomy from ENSAIA, Nancy, France in 1994

Training and Certification

  • GCP Auditor in 2018 Certification

Languages

BrightOwl Assessment:
Self Assessment:
English
Full Proficiency
French
Native
Spanish
Professional Proficiency

Work Preferences

  • Positions I am interested in:
    Clinical Research Associate (CRA) Senior Clinical Research Associate (CRA)
  • Locations I am interested in:
    France
  • Work From Home:
    Yes, 5 Days
  • Work Regime:
    BrightOwl freelancer :    40 Hours per week
  • International:
    Yes
  • Availability:
    Jan 2020 : 100%
    Feb 2020 : 100%
    Mar 2020 : 100%
    Oct 2019 : 100%
    Nov 2019 : 100%
    Dec 2019 : 100%

Area / Region

Paris, France

Others

Driving License
  • Yes

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