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Over 14 years experience in clinical research, I have gained wide experience as a CRA. I worked on various therapeutic areas across phase II to phase III clinical trials. A competently skilled, with a solid employment history. A team player that shares knowledge to improve team performance and quickly learns any new skills necessary to ensure the achievement of individual and corporate goals. Currently I’m looking for position as Senior CRA with leading responsibility or as junior CRA manager . Skills and responsibilities: - Administrative preparation of study site : financial contract, hospital extra cost, study documents, contact to laboratory and pharmacist. - Submission to Ethics committee and French CNOM - Independent conduct of site selection, initiation, monitoring and close-out visits. - Investigator’s site file, Trial Master File maintenance - Communication with site personnel & CRAs - Providing of study status reports - Represent the company on clinical sites and on external project meetings as required. - Knowledge in Good Clinical Practice requirements and their application to the conduct of clinical studies - Good organization and ability to travel Therapeutic Areas DMLA (wet and dry) BPCO Infections and infestations: - Hepatitis B - Hepatitis C - HIV/AIDS Neoplasms Benign, Malignant and Unspecified: - Breast Cancer - Chronic Lymphocytic Leukemia - Non-Small Cell Lung Cancer - Small Cell Lung Cancer - Malignant Melanoma - Myeloma - Lymphoma Cancer - Colorectal Cancer


Current Experience

  • Senior Clinical Research Associate (CRA)
    Since April 2015
    Managing of phase II-III protocols in Ophthalmology, Chronic Obstructive Pulmonary Disease, cardiology and respiratory disorders Competencies: - submission to Ethics Committee - feasibility - pre-study visits - initiation and monitoring visits - site status reports - contract management - study drug's accountability and materials management - investigator fees management

Past Experience

  • Senior Clinical Research Associate (CRA)
    February 2014 --- July 2014
    Implementation of new process in cosmetology studies to follow GCP and ICH regulations Qualification of CRO Implementation of TMF/SMF for ongoing and new studies Initiation, monitoring, and close-out visits Managing of study products Help the study manager to be in compliance with ICH and GCP on their studies Implementation of new documentation to be in compliance with ICH and GCP Review of German informed consent to verify if compliance with ICH Mentoring of colleagues CRA based in Romania and Bulgaria - refering CRA about new process and procedures

  • Confirmed Clinical Research Associate
    March 2006 --- December 2012
    Managing of phase II-III protocols in Breast Cancer, Lymphoma, Melanoma, Lung Cancer, Myeloma, Hepatitis B and C Competencies: - pre-study visits - initiation and monitoring visits - site close-out visits - site status reports - contract management - study drug's accountability and materials management - investigator fees management

  • Clinical Research Associate (CRA)
    January 2005 --- August 2005
    Clinical Trial phase III on the LLC with CD20+ Competencies: - initiation and monitoring visits - management and order of the pharmaceutical products - administrative management of the study

  • Clinical Research Associate / Assistant of a Study Manager
    November 2004 --- December 2004
    Clinical trial phase I on the colorectal cancer Competencies: - adaptation of the Monitoring Plan and the Study Reference Manual - creation of the Guide Nurse - management of a TMF for the closure of a clinical trial

  • Clinical Research Associate (CRA)
    October 2002 --- October 2004
    Management of a clinical trial of phase II/III on the lung cancer not to small cells of stage IIIA Co-administration of a clinical trial of phase II on the lung cancer not to small cells of stage I/II Competencies: - initiation / Monitoring visits - management of the SAE - design and management of the data base - seizure of the data/coding and emissions of the corrections - involved in the design of CRF following the protocol - involved in the drafting of information patient and informed consent for 2 protocols - involved in the design and the drafting of the newsletter of the IFCT as well as plates for the Investigators - involved in the drafting of the administrative file addressed to AFSSAPS and with the CCPPRB - management and order of the pharmaceutical products - involved in the update of Internet site of IFCT

  • Clinical Research Associate (training period)
    April 2002 --- September 2002
    Clinical trials on the HIV (15 tests in progress) Competencies: - CRFs completion - preparation of the visits of the patients (planning, kits blood...) - preparation of the monitoring visits of laboratory - involved in the preparation of a scientific publication (screening of patients)


Self Assessment :
AdaptabilityCharmAttention to detailCoordinationCuriosityEmotional reactivityFlexibilityInterest in knowledgeWillingness to compromiseTrust


Self Assessment :
Adverse Events (AE)Budget NegotiationClinical monitoringClinical Trial Management System (CTMS)Clinical Trial SuppliesClinical trialsContract negotiationCRFCROCTMSeCRFEDCGood Clinical Practice (GCP)ICH guidelinesInfectious diseasesOncology Clinical ResearchOphthalmologyPhase IIPhase III
LinkedIn Assessment :
ICH-GCPCROCTMSClinical trialsEDCGCPClinical DevelopmentoncologyRegulatory submissionsClinical researchPharmaceutical IndustryClinical Site MonitoringClinical monitoringSASInformDomaines thProtocolePharmaceutiqueGestionnaire de donnSOPSciences de la vieLaboratoireDCancermanagementEssais cliniquesValidationMaladies infectieusesAssociOpPharmacologieBiologie cellulaireBonnes pratiques cliniquesSecteur pharmaceutiqueRecherche cliniqueGestion des donn

Skills and Expertise

Self Assessment :
Assess site feasibilityAssess subject safetyAttend seminars, courses and meetings within and outside the companyCoach and provide guidance to clinical staff.Collaborate with PI and institution to respond to any audit findings and implement-approved recommendations.Collaborate with principal investigatorCollaborate with project teamCollaborate with medical teamCommunicate with sponsorConduct close-out visitsConduct site initiationConduct maintenance visitsCreate study documentsEnsure good clinical practice (GCP)Ensure consistency between the protocol and CRFEthics committee submissionsEthics committee applicationInitiate clinical trials Interact with ethics committeeManage clinical trial files/documentsManage Clinical Trial Management System (CTMS) Monitor dataRespond to audit findingsRetrieve study documentsReview informed consent processReview inclusion criteriaReview exclusion criteriaSchedule trial visitsSchedule sponsor monitoring visitsSelect investigatorsSelect sitesSerious Adverse Event (SAE) ReconciliationSite managementTrain on site staffUnderstand protocolsUpdate Clinical Trials Management System (CTMS) Use content management systemsWork collaboratively with the other members of the clinical research team


  • Data Manager degree in from Clinact Formation in 2013
  • CRA Certification, PPD CRA Foundation Course (Durham, USA) in Clinical Research from PPD in 2005
  • Clinical Research Associate degree in Clinical Research from Sup santé Lyon in 2002
  • Master's Degree 2 in Cellular Pharmacology and Pharmacochemistry from Université Louis Pasteur (Strasbourg I) in 2001
  • Master's degree in Physiology and Cellular Biology mention Physiology option Pharmacology from Université Louis Pasteur (Strasbourg I) in 2000
  • Bachelor's degree in Biochemistry from Université Louis Pasteur (Strasbourg I) in 1999


BrightOwl Assessment:
Self Assessment:
Professional Proficiency
Elementary Proficiency

Work Preferences

  • Notice Period:
    12 weeks
  • Positions I am interested in:
    Senior Clinical Research Associate (CRA) Clinical Project Manager (CPM)
  • Locations I am interested in:
    France Lyon, France Paris, France Switzerland
  • Work From Home:
    Yes, 0 to 2 days per week
  • Work Regime:
    BrightOwl employee :    100% FTE
  • International:

Area / Region

Paris, France


Driving License
  • Yes