Since University the world of clinical trials has attracted my interest, for this reason I attended a second level postgraduate master in "Preclinical and clinical development of drugs and post-marketing monitoring" that gave me the opportunity to do an internship as Clinical Project/Trial Aassistant in a CRO, that allowed me to improve my professional skills. I am able to interact with people of different cultures and nationalities thanks to my outgoing character. The features that distinguish me are: hard work, dynamism, motivation and passion for work. I put enthusiasm in everything I do and I always try to listen and help people when they need it. I am available to move for job.
July 2015 --- February 2016
Support Project Manager /Clinical Research Associate: Medical Writing – review and translation of Informed Consents Form, Protocol, synopsis and essential documents; Regulatory - collection site specific documents, submission request for authorization to Authority Committees AIFA and Ethics Committees and follow up submissions until obtaining opinion, updating of submission tracking systems, opening clinical sites; Study Agreements - negotiation economic agreements; Study files management – preparation, updating and archiving digital and paper documents of CE approval, Sponsor and investigators (Clinical Trial Master file, Trial Investigator’s File, Site Specific Folder e Trial Pharmacy File), preparation documents for clinical development plans (training materials and monitoring, presentations, clinical reports, scientific papers); Clinical Monitoring – SIV support and monitoring clinical sites remotely; Data management - remote monitoring of data recorded by sites and prompt insertion eCRF; Safety and Medical Monitoring - management of SAE and SUSARs and updating tracking files; EDC System - participation in eCRF development; IP Management - remote monitoring of stocks and shipments of the drug at the sites; Vendors management - selection of suppliers for necessary services to the management of trial; Participation in the planning of Investigator Meetings.
May 2013 --- May 2014
During this period I worked in a Clinical Analysis Laboratory as assistant Biologist. Receipt and storage of biological samples; Preparation and handling of biological samples; Microbiology Lab (optical microscope, cell cultures, antibiograms, Widal-Wright, TPHA); Hematology Lab (blood cell counter, blood groups, direct and indirect coombs test;) Molecular Biology Lab (HPLC, PCR, DNA and RNA extraction, enzymatic digestion, centrifuge, spectrophotometer).
January 2009 --- June 2009
I worked in a Organic chemistry laboratory: TLC and GC
AdaptabilityAnalytical thinkingCollaborationCommunicativeAttention to detailCuriosityDiligenceFlexibilityInterest in knowledgeOptimismProactivityProblem solvingReaction to stressSelf-confidenceSociabilityTrust
Skills and Expertise
Analytical skills Analyze data Assure medical quality Design case record forms Build and manage the Trial Master File (TMF) Develop clinical trial protocols Interact with physicians Interact with nurses Interpret data Monitor a clinical study Search literature on clinical trialsWrite final reportsAssist with site trainingAssist study siteAdministrative supportAdverse event reportingAdvise on medical perspectivesArchive documentationArchive study documentsArchive trial documentation and correspondence.Approve suitability of patient information and consent documentsAssemble regulatory applicationsAssess adverse reactionsCollaborate with project teamControl protocol versionsControl studiesCoordinate CMC-activitiescontrol different protocol versions and other essential documentsConduct site initiationAttend investigator meetingCreate clinical documents Control dataDesign clinical presentation
Second level postgraduate master in "Preclinical and clinical development of drugs and post-marketing monitoring" from University of Naples "Federico II" in 2016
Professional training course in Consultant for food hygiene and management of HACCP system from New Skill S.r.l, Naples in 2014
Master’s degree in Pharmaceutical Biotechnology from Second University of Naples in 2013
Professional Bilogist Qualification in from Second University of Naples in 2013
Bachelor’s degree in Biotechnology from Second University of Naples in 2009
High School in Diploma in Languages from I.S.I.S.S “ Giovan Battista Novelli”, Marcianise (CE) in 2005
Training and Certification
B2 level, Grade 7 (Trinity Collage Landon) in 2014 Certification