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study coordinator experience, CRA experience, Nurse Practitioner, project management experience, international research experience, wrote protocols, clinical team managemeny
QA/QC experience working with FDA ICH and Japanese regulations 21 CFR reviewing Writing editing submission documentation SOPs Protocols Reports. Product/Project analytical requirements evaluation budget in-house vs. out-source estimation. Upgrading of R&D laboratories to GLP/GMP level.
Ideal Companies: small start-up company
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methods transfer validation, phase I, II, III protocols and reports, GMP GLP, Laboratory management, hiring training budgeting, FDA ICH regulations, validation monitoring transfer, medical devices, Consulting, Document Review, Documentation, DSC, High Performance Liquid Chromatography (HPLC)
Vaud. L'Hôpital Cantonal de Fribourg Performed and led all start-up aspects for a Phase II multi-center study for Crohn's disease. Monitored 120 patients using a PAF antagonist for asthma, including pre-study visits, site initiations, monitoring, and close down. Wrote protocol and designed CRF for a methacholine challenge study. Monitored pharmacokinetic Phase I studies co-wrote final study report.
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Clinical Research, Research, C Programming Language, Consulting, Hepatitis, Hepatitis C, Pharmaceutical, Protocol, Filing, Health Insurance Portability And Accountability Act
Summary IT and Research Project management with 8 years of experience in research setting and 3 in software development. Set up training, wrote protocols, SOPs, managed scientist for large scale research project. Liaised between client and developers for a scalable sustainable practices programming software suite. Experienced with Intra-vitreal, Intra-cameral injection. Temporary Laboratory Technician, 8 months * Selected b...
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Adobe, Biomedical Industry, C Programming Language, Data Analysis, Hazardous Waste, Information Technology, Management, Microsoft Office, Microsoft PowerPoint, Notebook Computer
