Experienced Clinical Research Coordinator and Clinical Data Manager (phase II,III, IV studies) gradueted in Biological Sciences ready to take on new challenges in the world of clinical research, thanks to my previous experiences.
Panoramica
7
7
anni di esperienza professionale
1
1
Certificato
Esperienza lavorativa
Clinical Research Coordinator
WCG Clinical, Inc. (formerly WIRB-Copernicus Group)
Ospedali Riuniti Villa Sofia – Cervello, Palermo
2026.01 - ad oggi
Advanced Data Management (EDC Systems):Proficient user of Oracle InForm and Medidata Rave. Managed timely eCRF data entry, performed data cleaning, and handled proactive query resolution (DCFs) to meet Database Lock deadlines. Ensured data integrity (ALCOA+ standards) for complex protocols involving medical devices and biological drugs.
Randomization & Drug Supply (IRT/IWRS):Operational expertise in RTSM platforms, specifically Endpoint Clinical and Suvoda. Managed subject randomization (screening/baseline), emergency unblinding procedures, and Investigational Product (IP) accountability via portal, including temperature excursion management and quarantine release.
Regulatory & Site File Management (eISF/eTMF):Utilized Veeva Vault and SIP (Shared Investigator Platform) for regulatory document exchange and maintenance. Responsible for ISF updates, Ethics Committee correspondence, and ensuring audit readiness for monitoring visits (IMV) and Close-out visits (COV).
Lab Operations & Sample Logistics:Executed protocol-specific laboratory procedures, including PK/PD sampling with rigid timepoints, centrifuge processing, and sample shipment via central lab portals (Covance/LabCorp, Q2 Solutions). Managed local lab reference ranges updates.
Patient Flow & Coordination:Coordinated study visits from Pre-screening to Follow-up. Managed patient compliance tools including eDiaries (ePRO) and Quality of Life questionnaires. Organized specific diagnostic procedures (e.g., compatibility checks for dialysis devices) in collaboration with hospital staff
Clinical Study Coordinator Data Manager Asst
Grande Ospedale Metropolitano Niguarda
Milan, Mi
2023.10 - 2024.10
Management of clinical trials according to GCP, SOP and current regulations
Management of clinical studies, coordination of relations with sponsors and monitors
Assist CRA during SIV, MOV, COV and daily cooperation for the trials
Budget and billing management
Management of ECRFs with many different vendors
Ensure the proper conduct of phase II, III, IV to Italian ministerial decrees
Managing contacts with Ethics Committees
Management of IMP and laboratory kit
Drugs accountability
Collaboration in Informed Consent Form writing according to study protocols
Management of ISF and other activities
Trainee in Chemical and Biological Laboratory Analysis
Azienda Ospedaliera S. Antonio Abate
2018.03 - 2018.09
Laboratory analysis in hematology
Istruzione
MASTER'S DEGREE - HUMAN NUTRITION
Università T San Raffaele
03.2022
Clinical research training course "Missione CRA"
ClinOpsHub, Yghea CRO
2022-01
DEGREE - BIOLOGICAL SCIENCES
Università degli Studi di Palermo
10.2018
HIGH SCHOOL DIPLOMA - undefined
Liceo Scientico
01.2012
Competenze
Data Management
Teamworking
Fast Learner
Proactive Attitude
Communication
Adabptability
Thanks to my experience
L A N G U A G E S
Italian
Esperto
English
Avanzato
French
Base
Spagnolo
Base
Certificazioni
ICH GOOD CLINICAL PRACTICE E6(R3) with a score of 100% on 04/12/2025 This e-learning course has been formally recognised for its
Certicate of attendance with prot about the the transport of biological sampling in a clinical trial. IATA Dgr
Clinical research training course "ICH E6 (R2) GCP Investigator Site Personnel Training
references
References available upon request
Autorizzazione trattamento dati personali
Autorizzo il trattamento dei dati personali contenuti nel mio CV ex art. 13 del decreto legislativo 196/2003 e art. 13 del regolamento UE 2016/679 sulla protezione dei singoli cittadini in merito al trattamento dei dati personali
Cronologia
Clinical Research Coordinator
WCG Clinical, Inc. (formerly WIRB-Copernicus Group)
2026.01 - ad oggi
Clinical Study Coordinator Data Manager Asst
Grande Ospedale Metropolitano Niguarda
2023.10 - 2024.10
Trainee in Chemical and Biological Laboratory Analysis