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.
Senior Clinical Research Associate (CRA)Paris, France
Since February 2019
Attention to detailCollaborationCommunicativeCritical thinkingCuriosityEfficiencyFlexibilityIndependenceInterest in knowledgeOrganizationProblem solvingSelf-confidenceTrust
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
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
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