Trial Manager - HALT-IT Trial @ London School of Hygiene & Tropical Medicine
Clinical Project Coordinator, Early Clinical Development @ Quintiles
Laboratory Scientist, Biomarkers lab @ Quintiles London
MSc, Molecular Life Sciences @
King's College London
Trial Manager - HALT-IT Trial @ For more information about our exciting, international trial on Tranexamic Acid for the treatment of gastrointestinal bleeding you can visit our website. From March 2013 to Present (2 years 10 months) London, United KingdomClinical Project Coordinator, Early Clinical Development @ My role involved supporting the Clinical project Managers in all Clinical
Trial Manager - HALT-IT Trial @ For more information about our exciting, international trial on Tranexamic Acid for the treatment of gastrointestinal bleeding you can visit our website. From March 2013 to Present (2 years 10 months) London, United KingdomClinical Project Coordinator, Early Clinical Development @ My role involved supporting the Clinical project Managers in all Clinical Project Management activities. My duties included but were not limited to establishing and maintaining the Trial Master File, document tracking and archiving, quality control and query/issue resolution. Also, I assisted with Ethics and Regulatory submissions, draft project timelines, request project resources, organise and minute all trial-related meetings. Moreover, I liaised with various internal departments (pharmacy, regulatory,recruitment, labs, statistics etc) and with the sponsor to facilitate a smooth and timely study conduct from study set-up to Clinical Study Report delivery. I ensured that all work in conducted and recorded in accordance with ICH-GCP, local regulatory requirements, the clinical study protocol and company SOPs. I was involved with Investigational Medicinal Product (IMP) Phase I and early PhaseII studies, including First in Human, SAD, MAD, POC, bioequivalence and others spanning several therapeutic areas. From February 2012 to February 2013 (1 year 1 month) London, United KingdomLaboratory Scientist, Biomarkers lab @ I was involved in the processing of biological samples (respiratory samples and blood) in Phase I/IIa clinical trials, mostly concerned with respiratory conditions (asthma, COPD), while adhering to SOPs and working under strict GCP/GLP/GMP conditions.
I was also involved in certain aspects of project coordination and divided my time between the laboratory and the Project Management team. From December 2011 to February 2012 (3 months) London, United KingdomPhD student. Pharmaceutical Science Research Division @ I analysed the processing mechanism and molecular interactions of ADAM8, a protein molecule involved in inflammatory and invasive pathologies, such as allergic asthma and cancer (Thesis title: Cellular Processing and Molecular Interactions of the Metalloprotease-Disintegrin ADAM8).
I was also involved in non- laboratory tasks, such as organising and participating in weekly group meetings, presenting in seminars, preparing articles and grant proposals, ordering supplies, liaising with company representatives etc From 2007 to 2011 (4 years) London, United KingdomResearch Assistant @ I was involved in a project on the molecular pathogenesis of sporadic Amytrophic Lateral Sclerosis (ALS). I was responsible, among others, for the preparation, immunochemical staining and microscopic assessment of spinal cord tissue sections human from MND patients and control subjects. From November 2006 to June 2007 (8 months)
PhD, Molecular BIology, Biochemistry, Cell BIology, Metalloproteases, Cancer @ King's College London From 2007 to 2011 MSc, Molecular Life Sciences @ King's College London From 2004 to 2005 BSc (Hons), Human Genetics @ University of Leeds From 2000 to 2004 Nayia Golfi is skilled in: Cell Culture, ELISA, Tissue Culture, PCR, SDS-PAGE, Western Blotting, Immunofluorescence, Immunoprecipitation, Cell Based Assays, Clinical Project Management, Teaching, CTMS, MS Project, Regulatory Submissions, Root Cause Analysis, Trial Management, Clinical Research, Cell
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