Clinical Project Manager and CRA

• Feb 2022 - Present

Clinical Research Coordinator

• Mar 2019 - Feb 2022

Clinical Research Coordinator at the Department of Hematology AOU Careggi, Florence. Data Manager/Study Coordinator in profit and no profit Oncohaematological clinical studies (phase I-IV lymphomas). Main activities: - Relation to CROs, Ethics Committee, Principal Investigator and other physicians. - New study agreement organization and site initiation, monitoring, close-out and auditing visits; - Submission and management of ethical and administrative authorization procedures for the activation of trials: primary point of contact for the sponsors and the local EC for the amendments and revisions of the essential documents; - Review the study budget proposed by the Sponsors and align it with the hospital benchmarks; - Medical writing for the new clinical studies (protocol, ICF, questionnaires, MTA, essential documents); - Cooperate with the PI and study staff to identify eligible patients; - Management and review of study documentation archiving (IF, TMF); - Data management: collection of clinical data during the trial and their transfer to the electronic CRF (with different eCRFs) and queries resolution; - Management of Pharmacovigilance aspects: notification of any SAE / SUSAR to the promoter and to the EC; - SOP writing; - Management of Investigational Product (IP): Experimental drug accounting and assignment through the IWRS system; - Interaction with the clinical monitor and management of monitoring visits; - Processing, storage and sending biological samples to centralized laboratories. Show less

Master Degree Internship

• Jan 2018 - Oct 2018

Experimental internship with a project titled: “Study of SLPI regulation in cellular and mouse models of prostate cancer”. Experimental in vitro e in vivo models of prostate cancer. In particular with the aim of identifying the role of ETS factors in the pathogenesis of prostate cancer. Experimental internship with a project titled: “Study of SLPI regulation in cellular and mouse models of prostate cancer”. Experimental in vitro e in vivo models of prostate cancer. In particular with the aim of identifying the role of ETS factors in the pathogenesis of prostate cancer.

Undergraduate Internship

• Sep 2015 - Apr 2016

Experimental internship with a project titled: "Role of mitochondrial metabolism in the progression of prostate cancer induced by the tumor microenvironment". Experimental internship with a project titled: "Role of mitochondrial metabolism in the progression of prostate cancer induced by the tumor microenvironment".