Natascia Caroccia

Clinical Research and Clinical Project Management professional with over six years of experience coordinating investigator-initiated and sponsor-sponsored clinical studies in Infectious Diseases within a leading Italian public Academic Research Hospital (IRCCS).

Proven expertise across the clinical trial lifecycle, including study start-up, regulatory submissions, multicentre study coordination, clinical operations, REDCap database management, and cross-functional collaboration with investigators, sponsors, CROs and regulatory authorities.

Holding a PhD in Cancer Biology and a Master's Degree in Clinical Study Coordination, I combine strong scientific expertise with hands-on operational experience to ensure regulatory compliance, study quality and successful project delivery.

• Coordinated 30+ investigator-initiated observational studies, including multicentre international projects.
• Supported the operational management of Phase II–IV clinical trials sponsored by pharmaceutical companies and non-profit organisations.
• Managed regulatory submissions to AIFA (RSO) and study registrations on ClinicalTrials.gov.
• Prepared documentation supporting CTIS submissions.
• Administered REDCap databases and designed eCRFs for investigator-initiated studies.
• Contributed to the management of a Horizon 2020 European research project on COVID-19.
• Collaborated with 5–10 pharmaceutical sponsors and 5–10 CROs.
• Supported clinical research involving datasets of over 10,000 participants across investigator-initiated and sponsor-sponsored studies.

• Clinical Project Management
• Clinical Trial Coordination
• Study Start-up and Site Management
• Regulatory submissions (AIFA, Ethics Committees, CTIS, ClinicalTrials.gov)
• ICH-GCP E6(R3) compliance
• REDCap Administrator (database development, eCRF design, data quality, reporting, data export)
• Investigator Site File (ISF) management
• Trial Master File (TMF) support
• Monitoring visits, audits and inspection readiness
• Budget and contract review
• Protocol & ICF Review
• Investigator Meetings and stakeholder management
• Collaboration with Sponsors, CROs and multidisciplinary teams

• ICH-Good Clinical Practice E6 (R3) certificate
• IATA training for transportation of dangerous goods
• Qualified Biologist (Italy)

Publications are available at PubMed profile: https://pubmed.ncbi.nlm.nih.gov/?term=caroccia+n

In compliance with the Italian Legislative Decree no. 196 dated 30/06/2003, I hereby authorize the recipient of this document to use and process my personal details for the purpose of recruiting and selecting staff and I confirm to be informed of my rights in accordance to art. 7 of the above mentioned decree.