Javier González Vázquez
CRA at Clinical Trials Team- Claim this Profile
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Bio
Experience
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Clinical Trials Team
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Spain
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Pharmaceutical Manufacturing
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1 - 100 Employee
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CRA
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Jan 2017 - Present
♣ Start-up phase preparation. ♣ Contract and economic budget preparation. ♣ Preparation of Ethics committee and regulatory documentation. ♣ Site master file preparation and review. ♣ Review of protocol and informed consent translation and adaptation to Local Law. ♣ On-site and remote monitorization. ♣ Site evaluation visits, site initiation visits, site monitoring visits and site close out visits organization and performance. ♣ Co-Monitoring and close- out visits performance. ♣ Follow up letters and monitorization reports preparation. ♣ Review of eCRF with sites Bioclínica, Openclinica, and EDC remotely. ♣ Query management and resolution with the site staff team. ♣ Reconciliation of investigational product in the site. ♣ Health areas: oncology (Phase III and Ib), onco-hematology (Phase III), nephrology (Observational study), allergies (Phase II), anaesthesiology (Phase IV), rare diseases (Phase III). Show less
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osakidetza
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Spain
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Wellness and Fitness Services
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700 & Above Employee
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Department of Immunopathology, Biocruces (Osakidetza).
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2015 - 2016
Research: Adoptive cell therapy with autologous cytokine-induced memory-like (CIML) Natural Killer (NK) cells transplantation to treat Acute Myeloid Leukemia patients. ♣ Growth of transform cell cultures. ♣ Isolation of peripheral blood mononuclear cells (PBMCs). ♣ CIML NK cells generation with cytokines IL-12, 15 and 18 exposure. ♣ Dose optimization experiments with IL-2. ♣ Assessment of antitumor competence of CIML NK cells in presence of the JAK/STAT inhibitor ruxolitinib. ♣ Spectrofluorometric assessment to determine cytotoxicity of NK cells. ♣ Flow Cytometry to assess proliferation, surface receptors and degranulation of NK Cells. ♣ Use of antibodies. ♣ Use of specific software: Flowjo v10.0.7(Tree star), Graph Pad Prism 7a. ♣ Bibliography review. Show less
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ZTF-FCT :: UPV/EHU
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Spain
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Higher Education
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1 - 100 Employee
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Department of Immunology, Microbiology and Parasitology
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2012 - 2015
Research: Study of the interactions of glycolytic enzymes in Escherichia coli using the double hybrid technique and genetic engineering protocols. ♣ Development of a double hybrid experiment based on Beta- galactosidase reaction. ♣ Growth of E. coli using Luria Bertani (LB) and MacConkey medium. ♣ Design of “primers” with specific software. ♣ Use of PCR technics to amplify primers. ♣ Quantification of DNA using agarose and acrylamide gels and specific software. ♣ Quantification of bacteria using spectrophotometry. ♣ Applying electroporation, heat stock and chemical technics to insert plasmids into E.coli bacteria. ♣ Protein isolation with Chromatography and quantification and identification using Western Blot techniques. ♣ DNA and RNA isolation with commercial KITs. Show less
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Education
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Universidad Católica de Valencia San Vicente Mártir
Master Degree in Development and Monitorization of National and International Clinical Trials -
Universidad del País Vasco/Euskal Herriko Unibertsitatea
Master Degree in Molecular Biology and Biomedicine -
Universidad del País Vasco/Euskal Herriko Unibertsitatea
Degree in Biology, Biochemistry and molecular biology