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Summary

Currently available full time. More than 12 years of experience in clinical trials as Clinical Research Associate (freelance role and permanent role), I have been involved on various projects within pharmaceuticals companies and CROs. I do have a strong experience in phase II and III (France and Belgium), ATU, late phase (observational registry) and epidemiological studies. Reactivity, suppleness and availability. I am focused on good communication, organization and trials logistics ensuring data quality and allow to bring success of your trials.

Experiences

Current Experience

  • Senior Clinical Research Associate (CRA)
    Since January 2002
    Professional Experience : Responsabilities include : -Clinical trial feasability (site identification and assessment). - Start-up Activities (selection sites, contracts negotiation, agreement redaction englich/french) -Regulatory activities (EC submission, ANSM, CNOM, CNIL, CCTIRS). Submission protocol amendments. -Site Management (Training of medical staff to studies, Coordination of sites activities). -Full site Monitoring Activities (Site Initiation Visit, Monitoring, Adverse event management,drug management, Close-out Visit). -Follow-up Investigators payment. -Assist for redaction of inform consent form in french language. -Assist for review eCRF and protocol redaction. -Assist sites to boost recruitment. Therapeutic Experiences : -Oncology metastatic melanoma, observational study. -Pneumology Fibrosis Pulmonary idiopathic, observational registry -Cardiology coronary syndrome, phase IIIb -Geriatry epidemiological evaluation for admission of old person at the hospital -Oncology chronic myelogenous leukemia, phase III -Oncology metastatic melanoma in stade IV, phase III -Endocrinology type II diabetic patients, phase II -Dysfunction erectile Trouble of erection, phase IV -Medical device in gastroenterology Prevention of the post-operative adhesions during the surgery by laparotomy,phase IIIb -Urology safety and efficacy study in the treatment of neurogenic overactive bladder, phase II -Pneumology pneumonia acquiered in community, phase II -Gynaecology treatment for premenstruel syndrome, phase IV -Endocrinology measure of the cetose in the blood for diabetic patient , phase II/III -Dentistry phase IV Complication infectious of the peri coronarites aiguees, phase IV -Infectiology HIV temporary authorization for use, cohort ATU -Genetic fabry disease child, phase II and III -Oncology earlier treatment for patients affected by lung cancer, phase II and III -Dermatology vitiligo, psoriasis, herpes, phase II and III

Knowledge

LinkedIn Assessment :
ContractorsClinical trialsClinical researchClinical monitoringICH-GCPRegulatory submissionsRegulatory affairsRedaction Interne ProceduresReview Interne ProceduresContract negotiationCROPharmaceutical IndustryEDCMedical DevicesTherapeutic AreasEssais cliniques

Education

  • One year course in research techniques in Biological research from Ecole Pratique des Hautes Etudes La Sorbonne Paris in 2000
  • Bachelor’s degree in science in Cellular and Molecular Biology, Animal Physiology from Université de Reims Champagne-Ardenne in 1998

Area / Region

France

Others

Driving License
  • No