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Italy2612
CRA
Contato
Competências
Performed initiation, interim, and close-out visits, ensuring quality and compliance in multicenter vaccine studies.
Conducted Source Data Verification (SDV) and managed reporting through EDC and other reporting systems.
Reviewed investigator files, managed site communications, and supported site staff training and queries.
Oversaw accountability of investigational products using IVRS and related systems.
Reviewed prescriptions and managed inventory including expiration control in a hospital pharmacy setting.
Formação acadêmica
Idiomas
Resumo
Dedicated CRA with over 8 years of expertise in conducting and overseeing vaccine clinical trials, ensuring compliance, data integrity, and subject safety across diverse populations.
Principais conquistas
- Conducted monitoring visits for multiple Phase II, III, and IV vaccine clinical trials across various demographics.
- Reviewed investigator files ensuring compliance and subject safety; supported site initiation and qualification activities.
- Managed on-site data verification and reporting using EDC systems like Veeva Vault and in-house platforms.
Experiência
CRA
Clinical Research Associate on 2 phase II, multicenter, open, blind, randomized Clinical trials in Vaccines (Norovirus) in children and Covid/FLU in adults and older., Performed initiation, interim and close out monitoring visits., Perform SDV during on-site visit using EDC, and reporting using Veeva Vault system for reporting., Review on site Investigator’ files and ensured subject safety by overseeing timely and accurate AE/SAE reporting and follow up, accountability of supplies and management., Maintained regular site staff contacts, training, and query support., Pre-study activities for study in pregnant women., Site selection visits and qualification visits., Preparation site initiation visit material for study Covid/FLU.
CRA
Clinical Research Associate on 2 phase III and IV, multicenter, open label, blind, randomized Clinical trials in Vaccines (RSV) with pregnant women and Epidemiological study where the follow up to surveillance sibilance and asthma cases in children., Performed initiation, interim and close out monitoring visits., Perform SDV during on-site visit using EDC, and in-house e-track system for reporting., Review on site Investigator’ files and ensured subject safety by overseeing timely and accurate AE/SAE reporting and follow up., Use IVRS for IP set up, accountability and management., Maintained regular site staff contacts, training, and query support.
CRA
Clinical Research Associate on 2 studies phase III and IV multicenter, open label, blind, randomized Clinical trials in Vaccines (RSV) with pregnant women and epidemiological study where the follow up to surveillance sibilance and asthma cases in child., Performed initiation, interim and close out monitoring visits., Perform SDV during on-site visit using EDC, and in-house e-track system for reporting., Review on site Investigator’ files and ensured subject safety by overseeing timely and accurate AE/SAE reporting and follow up., Use IVRS for IP set up, accountability and management., Maintained regular site staff contacts, training, and query support.
Hospital Pharmacy
Reviewed prescriptions, dispensed medications., Accountable for inventory management and expiration control of products.