Study Coordinator and CRA Trainee
July 2016 --- April 2017
• Phase II-IV activities related to clinical oncological studies (Support medical staff in SIV, SMV and close-out visit ; analysis of site feasibility: number of enrolled patients, inclusion/exclusion criteria, patient randomization, identification of competitive studies, verification of resources adequacy; samples collection in compliance with GCP and shipment organization to central or local laboratories; investigational drug accountability; report of clinical data in eCRF; queries resolution; AE/SAE report).
Regulatory Affairs Associate
July 2016 --- April 2017
• Clinical research documents submission to OsSC (reviewing and translation of clinical documents; support to PIs and researchers for the CTA form drafting).
• Submission of site-specific documents to local EC; submission of periodic updates to local EC.
Post doctoral Reserch Fellow
May 2013 --- August 2016
• Research activity: Preclinical research in oncology and cellular biology and characterization of the molecular mechanisms leading to cancer progression (cell culture; analysis of nucleic acids; analysis of proteins; management of transgenic murine lines: mice phenotypical analysis, collection of MEFs, MEFs and mESCs tecqnique differentiation)
• Two first author papers in scientific international journals
Postdoctoral Research Visiting Fellow
April 2015 --- June 2015
• Research activity: Molecular oncology and cellular biology
Skills and Expertise
Interact with physicians Interpret data Monitor a clinical study Report data Search literature on clinical trials Write papers Technology researchAnalyze proteinApprove queriesArchive documentationArchive study documentsArchive trial documentation and correspondence.Assess adverse reactionsAssemble regulatory applicationsAssess site feasibilityAssess subject safetyassess the needs of the project(s)/program(s) and make changes in process, work flow and/or assignments.Assist with proceduresAssist with experimentsAttend seminars, courses and meetings within and outside the companyCell cultureCollaborate with medical teamCollaborate with principal investigatorCollaborate with project teamCollect dataCollect patient forms and questionnairesCollect financial data from hospitalsComplete case report form (CRF)Complete study proceduresConduct animal studiesConduct close-out visitsConduct research at universitiesConduct studiesConduct site initiationConduct university research Control protocol versionsCoordinate with the ethics commiteecoordinating research projectsEnsure good clinical practice (GCP)Ethics committee submissionsExecute scientific projectsFeasibility analysis of proposed trial designGuide studentsInteract with CROsInteract with pharmacistsInteract with physiciansInteract with pre-clinical scientistsManage multiple projectsManage trial master file (TMF)Manuscript preparationManuscript preparation and reviewOrganize scientific projects (in biology)Patient recruitmentpcrPre-study procedures Publication of articlesRegulatory submissionsRegulatory documentationReport serious adverse events (SAE)Research at universitiesResolves queriesScreen patientsShipment of biological specimenSite managementSolve problemsSupervise PhD studentsSupervise techniciansTeachingUse laboratory techniquesUse western blotting techniqueWork collaboratively with the other members of the clinical research team Write papers
Master 2° Livello in "Sviluppo preclinico e clinico dei farmaci e monitoraggio post-marketing" from Università degli Studi di Napoli 'Federico II' in 2017
PhD, Oncology and Molecular Endocrinology in from Università degli Studi di Napoli 'Federico II' in 2013
Master's Degree (2 years) in Medical Biotechnology from Università degli Studi di Napoli 'Federico II' in 2009
Bachelor's degree (3 years) in Biotechnology for Health - Medical Curriculum from Università degli Studi di Napoli 'Federico II' in 2007
in from Comprehensive Cancer Center, Medical Center, The Ohio State University, Ohio, USA in 0
Partecipant at First Novartis Biotechnology Leadership Camp in from Centro di Ricerca e Sviluppo di Novartis Vaccines, Siena, Italy in 0
Training and Certification
Transcelerate ICH-GCP Training Certificate in 2016 Certification