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OTR3
- Clinical research Associate
2012 - maintenant
Management and monitoring in clinical trials on medical devices and matrix treatments :
• Conception and submission of Clinical trials applications ;
• Study initiation, ongoing monitoring visits and study close outs (administrative, logistical and operational follow-up) ;
• Help to clinical project management.
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AFSSAPS
- Substantial amendment Manager and regulatory Assessor
Saint-Denis
2011 - 2011
Substantial amendment files management and regulatory assessment in clinical trials on medicinal products for human use :
• Assessment of technical and regulatory admissibility ;
• Determination of the necessary assessments (clinical, preclinical, quality…) ;
• Management of scientific assessment (tracking time) ;
• Communication with applicants and sponsors (advices on substantial modifications applications content and form, progress in the assessment of requests).
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INSERM U940
- Research Technician
2009 - 2009
Studies of calcium homeostasis in cell lines derived from mantel cell lymphoma, and modulation of calcium dependent cell activation by 2-APB (and some conformational analogues) :
• Cell culture in sterile conditions ;
• Biochemistry and cell biology techniques ;
• Research project starting.
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INSERM U718
- Research Technician
2008 - 2008
Study of calcium homeostasis and modulation of calcium-dependent leukocyte activation by 2-aminoethyl diphenylborinate (2-APB) and some conformational analogues :
• Cell culture in sterile conditions ;
• Intracellular calcium concentration monitoring ;
• Literature monitoring.
