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.
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 science)" rel="nofollow">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 science)" rel="nofollow">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 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
LinkedIn Assessment :
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
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