Marzia Guerrieri

Clinical Research Coordinator with hands-on experience in site-level clinical trial operations within an IRCCS, supporting the operational and regulatory management of interventional and observational studies across multiple therapeutic areas.

Clinical Research Coordinator at Policlinico Universitario Agostino Gemelli IRCCS (2024-01 – Present)

Experience in profit and non-profit interventional and observational clinical trials across multiple therapeutic areas, including Urologic Oncology (Phase II), Gastroenterology and Gut Microbiota (FMT), Allergy and Immunology, Rheumatology (Phases II–IV), and immune-mediated diseases.

• Coordinate site-level clinical trial activities in compliance with ICH-GCP, SOPs, sponsor requirements and applicable regulatory standards.
• Act as site-level point of contact for CRAs, sponsors, investigators, Ethics Committees and central laboratories.
• Support Site Initiation Visits, Monitoring Visits and Source Data Verification (SDV) activities, contributing to protocol compliance and data quality.
• Support informed consent documentation, Ethics Committee submissions and protocol amendment activities.
• Support AE/SAE documentation and follow-up activities in collaboration with investigators, CRAs and sponsors.
• Manage essential documents and site-level TMF activities, ensuring filing accuracy, version control and inspection readiness.
• Perform eCRF completion, data entry and query resolution activities using Medidata Rave, REDCap and Veeva Vault.
• Coordinate operational Fecal Microbiota Transplantation (FMT) activities, including donor workflow management, donor screening procedures and microbiota traceability.
• Coordinate biological sample handling, microbiota donor screening activities and shipment processes, ensuring protocol compliance, traceability and chain of custody.

Clinical Data Entry Support at Policlinico Universitario Agostino Gemelli IRCCS - UOC Child Neuropsychiatry (2024-01 – 2024-12)

• Supported clinical data entry, documentation, data quality, and study close-out activities in compliance with ICH-GCP, SOPs, and Good Documentation Practice (GDP).

Preclinical Research Apprenticeship at University of Rome Tor Vergata (2022-01 – 2022-12)

• Conducted preclinical research on the role of Niclosamide in Amyotrophic Lateral Sclerosis and Friedreich's Ataxia using mouse models, applying molecular biology techniques including PCR, qRT-PCR, Western blot, and immunofluorescence.

Clinical Sample Collection and Processing Support at Sicur Medical (2021-01 – 2022-12)

• Collected and processed SARS-CoV-2 nasopharyngeal swab samples, performed administrative tasks, and managed data entry into ASL systems for official reporting and sample tracking, ensuring confidentiality, accuracy, and accountability in healthcare data management.

Second-level Master in Clinical Research, Medical Affairs, Drug and Medical Devices – Guglielmo Marconi University (2023-01 – 2025-12)

Master's Degree in Molecular, Cellular and Biomedical Sciences – University of Rome Tor Vergata (2020-01 – 2022-12)

Bachelor's Degree in Biological Sciences – University of Salento (2016-01 – 2019-12)