Federico Mazzacane

Background

About Federico Mazzacane

Education - Master’s Degree in Pharmacy and Industrial Pharmacy – University of Chieti, Italy – (19 July 2013) Certifications - ICH GOOD CLINICAL PRACTICE E6(R3)(06 AUG 2025) with a score of100%- CRA License – Certificate of Recognition, awarded via DC Solutions Srls / Lèon Research – (06 December 2022)(According to the Italian Ministerial Decree of July 15, 1997). CRA Training and Experience - Clinical Research Associate at ClinChoice – from March 2023 – Present. Actively involved in the management and monitoring of clinical trials across multiple sites, ensuring compliance with protocols, ICH-GCP guidelines, and regulatory requirements. Responsibilities include conducting site visits (initiation, monitoring, and close-out), performing SDV, supporting safety event reporting, and liaising with investigators and site staff. Trials include interventional Phase studies- Junior CRA at Leon Research - from June 2022 to December 2022. Attended the CRO for over 4 months to perform hands-on activities in the monitoring and oversight of investigational medicinal products and clinical trials. Completed 10 days of on-site monitoring visits accompanied by senior CRA from Lèon Research (Clinical Trials Phase Interventional, Medical Devices not CE marked). Key Competencies and Responsibilities - Maintains up-to-date knowledge of scientific, regulatory, and operational aspects relevant to assigned clinical trials - Supports site selection, feasibility, and initiation, ensuring accurate pre-study documentation - Delivers site training on study procedures to ensure compliance with protocol and ICH-GCP standards - Conducts and documents monitoring visits, ensuring CRF accuracy and overall data quality - Performs Source Data Verification (SDV) and oversees the resolution of data queries in a timely manner - Manages investigational product (IP) and study material supply at the site level - Supports site personnel in the reporting and follow-up of safety events (AEs, SAEs, SUSARs)- Oversees study close-out procedures and archiving activities - Escalates issues impacting trial conduct to Project Managers (PMs), Senior PMs (SPMs), or Project Coordinators (PCs)- Reports all site activities and submits documentation to the Clinical Monitoring Unit (CMU-H) in accordance with timelines - Assists in the preparation of CRFs and site start-up documentation - May contribute to regulatory submissions (e.g, EC/CA submissions, informed consent forms) upon appropriate training - May take on Feasibility Associate (FEA) tasks following training