Vanessa D’Urbano
Bologna
Profilo professionale
Professional with a strong scientific background developed in an academic laboratory setting and further strengthened within the clinical research industry. My experience in laboratory environments has provided me with a solid technical and methodological foundation, while my transition into the Study Manager role has enabled me to expand my competencies in study oversight, quality management, and operational coordination.
Panoramica
12
12
years of professional experience
Esperienza lavorativa
Study Manager
IQVIA Italy Solutions S.r.l.
Smart working
2023.12 - ad oggi
· Plan and finalize study activities ensuring compliance with protocol and ICH/GCP
· Coordinate regulatory dossier preparation and communication flow with sites
· Manage Investigator meetings and risk analysis for study deviations
Clinical Project Manager
SIDeMaST S.r.l.
Roma, RM
2023.10 - 2023.11
· Support research groups and pharma companies in regulatory documentation
· Design registries and eCRFs in collaboration with statisticians
- Collaborazione con i colleghi nell'esecuzione delle attività assegnate.
- Gestione delle attività assegnate in piena autonomia grazie alle competenze maturate.
Clinical Research Coordinator
IRCCS Istituto Romagnolo per lo studio dei tumori “Dino Amadori” (IRST) S.r.l.
2021.06 - 2023.09
- Biostatistics and Clinical trial Unit
- Collaborazione con i colleghi nell'esecuzione delle attività assegnate.
- Esecuzione rapida e precisa delle attività assegnate.
- Gestione delle attività assegnate in piena autonomia grazie alle competenze maturate.
PostDoc Position
University of Bologna
2020.11 - 2021.06
- HIV Research at the Microbiology Section of the Department of Experimental, Diagnostic and Specialty Medicine, School of Medicine
Assistance and Research activity for COVID-19 emergency
Sant’Orsola Hospital, Bologna
2020.04 - 2020.10
- CRREM Laboratory (Centro di Riferimento Regionale per le Emergenze Microbiologiche), Microbiology Section
PhD
University of Bologna
2017.11 - 2020.10
- Biomedical and Neuromotor Sciences at the Microbiology Section of the Department of Experimental, Diagnostic and Specialty Medicine, School of Medicine
Internship period
INSERM/CEA U1184 Laboratory of Bicêtre hospital, Paris Sud, France
2019.11 - 2020.03
Internship
Medical and Molecular Genetics Laboratory of “Sacro Cuore” Catholic University, Rome
2011.07 - 2014.07
Istruzione
PostDoc Position - HIV Research
University of Bologna
2021-06
PhD - Biomedical and Neuromotor Sciences
University of Bologna
2020-10
Master degree - Pharmaceutical Biotechnology
Alma Mater Studiorum, University of Bologna
Bologna2016-11
Bachelor’s degree - Health Biotechnology
Catholic University of “Sacro Cuore”
Rome2014-03
Competenze
- Laboratory
- Drawing up research protocols for clinical research studies of PRIN2015 and PRIN2017; patients enrollment for clinical studies, CRF compilation; forms preparation for the project research (PRIN2015 and PRIN2017) submission at the local Ethics Committee (protocols, synopsis, information and informed consent for the processing of personal data and participation in the study, CRF)
- Basic microbiological techniques: bacterial isolation and set up of pure cultures, identification tests for bacterial species, Gram staining, antibacterial drugs activity assays
- Cell cultures: culturing of mammalian primary cells and cells lines, HIV-1 isolation, propagation and infection, cell stimulation with IFNs, in vitro analysis of molecular compounds, flow cytometry analysis; Chemical and plant compounds analysis as potential antimicrobial/viral agents
- Molecular biology: cloning, transformation of competent bacteria and plasmid DNA purification; transfection of eukaryotic cells; SDS-PAGE and Western Blot; analysis with hematoxylin-eosin, immunocytochemistry, and immunofluorescence; flow cytometry analysis; preparation of DNA probes labeled with digoxigenin, hybridization in situ and on filter assays; proliferation assays and cell toxicity; Southern Blot; purification of nucleic acids; DNA and RNA extraction; Real Time qPCR, RT-PCR, DNA electrophoresis on agarose gel SARS-CoV-2 detection: RT-PCR test performed on nasopharyngeal swabs and other upper respiratory tract specimens, such as throat swab and sputum
- In vivo models: in vivo analysis of genes in mouse models
- Computer skills: excellent knowledge of MS Office programs (Word, Power Point and Excel), good knowledge of GraphPad, PubMed, NCBI, SnapGene DNA, FlowJo software
- Organization of experiments timelines, teamwork support
- Tutoring activity in “Microbiology and Microbiological Analysis” and “Pharmacy Microbiology and Public Health, elements of epidemiology- microbiology and public health
- Clinical Research
- Management of interventional e non interventional studies:
- - Set up of study timeframes and risk assessment plan;
- - Preparation of feasibility questionnaires to centers to be involved in a multicenter clinical trial study
- - Preparation of EDC system for patient data collection
- - Preparation of all essential documents in compliance with regulations, internal procedures and study protocol
- - Management of regulatory affairs for the request of authorization in studies conduction (and their amendments) to Ethics Committees and Competent Authorities (AIFA, Ministry of Health)
- - Verification and monitoring of study staff compliance with study protocol, patients enrollment and work in collaboration with study monitor
- - Management of Investigator meeting, preparation of study newsletters
- - Preparation and constant maintenance of TMF in compliance to quality procedures
- - CTgov registration of new clinical trial studies
- - EudraCT database completion with ended studies results
- - Preparing Internal SOPs
- - Preparation of all documents linked to Privacy Treatment according to GDPR and in collaboration with Privacy reference office and DPO
- - Preparation of eCRF and guidelines of eCRF completion
- Excellent knowledge of MS Office programs (Word, Power Point and Excel)
- Good knowledge of GraphPad, PubMed, NCBI, SnapGene DNA, FlowJo software
- Good knowledge of R system, ECD System, RedCap and Open Clinica platform
- As Clinical Research Coordinator, I operate in compliance with current regulations, ICH/GCP Guidelines and internal procedures of the institute I independently menage the study start up and data management
- I am a dedicated and enthusiastic worker, with good organizational and management skills, developed through work in different environments
- I have the ability to multi-task, to self organize the job, to plan activities define priorities and responsibilities, to meet deadlines, to identify and creatively resolve problems
- My past experiences covered different research areas (molecular and cellular biology, microbiology) in different contexts and my current status as a CRC has provided me with a comprehensive understanding and utilization of scientific and ethic principles
LANGUAGE SKILLS
French B2 B2 B2 B2 B2
Intermedio avanzato
English B2
Avanzato
FURTHER INFORMATION
- Scientific Publications
- New Microbiol. 2021 May 1;44(2). (PMID: 33978194; online ahead of print).
- J Virol Methods. 2020 Feb;276:113778 (doi: 10.1016/j.jviromet.2019.113778) .
- Curr HIV Res. 2018;16(3):184-207 (doi: 10.2174/1570162X16666180817115830).
- Health Sci Rep. 2018;1:e31 (doi: 10.1002/hsr2.31).
- New Microbiol., 2017: 40 (1) 1-10 (PMID: 28217185).
- Curr HIV Res. 2017;15(6):448-455 (doi: 10.2174/1570162X16666171206121026).
- Eur J Hum Genet. 2015 Dec;23(12):1673-8 (doi: 10.1038/ejhg.2015.52).
- Posters and Congress Participations
- 12 National Congress ICAR, Rome, October 12-16, 2020.
- 47 National Congress of the Italian Society of Microbiology, Rome, Sept 18-21, 2019.
- 6 European Seminars in Virology (EuseV), Bertinoro, 22nd-24th June 2018.
- 10 National Congress ICAR, Rome, May 22-24, 2018.
Disclaimer
I authorize the processing of my personal data in accordance with GDPR (EU Regulation 2016/679).
Qualificaziones
- Biologist and registration as biologist from 15/01/2021
- Driving license, category B
ATTIVITÀ DI TUTORING
Outside of my professional role, I am involved in tutoring and academic support for university students, providing guidance in study planning and exam preparation. I have gained particular experience in supporting students with learning disabilities (DSA), adapting teaching methods to promote effective and personalized learning.
Cronologia
Study Manager
IQVIA Italy Solutions S.r.l.
2023.12 - ad oggi
Clinical Project Manager
SIDeMaST S.r.l.
2023.10 - 2023.11
Clinical Research Coordinator
IRCCS Istituto Romagnolo per lo studio dei tumori “Dino Amadori” (IRST) S.r.l.
2021.06 - 2023.09
PostDoc Position
University of Bologna
2020.11 - 2021.06
Assistance and Research activity for COVID-19 emergency
Sant’Orsola Hospital, Bologna
2020.04 - 2020.10
Internship period
INSERM/CEA U1184 Laboratory of Bicêtre hospital, Paris Sud, France
2019.11 - 2020.03
PhD
University of Bologna
2017.11 - 2020.10
Internship
Medical and Molecular Genetics Laboratory of “Sacro Cuore” Catholic University, Rome
2011.07 - 2014.07
PhD - Biomedical and Neuromotor Sciences
University of Bologna
Master degree - Pharmaceutical Biotechnology
Alma Mater Studiorum, University of Bologna
Bachelor’s degree - Health Biotechnology
Catholic University of “Sacro Cuore”
PostDoc Position - HIV Research
University of Bologna