Clinical Research Associate (CRA)
Since February 2014
I'm now involved in more complex clinical trials. The following duties are carried out with the leading guide of my personal experience and the goal to contribute towards efficient management of trials: - to assist the Project Managers (PMs) in the preparation and review of protocols and informed consent forms; - to contribute to Case Report Form (CRF) design and clinical trial document development as they pertain to clinical monitoring activities (Le. operating manuals, monitoring guidelines, etc.); - to be involved in recruitment of potential investigators, preparation of Independent Ethics Committee/ Independent Regulatory Board (IEC/IRB) submissions, notifications to regulatory authorities, translation of study related documentation, organisation of meetings and other tasks as instructed by the PM; - to negotiate investigator budgets and assists with the execution of site contracts with support from the legal department; I oversee all aspects of study site management to ensure high quality data resulting in consistently low query levels and in good Quality Assurance reports; - to establish updates, track and maintain study specific trial management tools/systems, and status reports; - to perform pre study visits, initiation visits, monitoring visits, close out visits; - to communicate effectively with site personnel, including the Principal Investigator (PI), and CRO management to relay protocol/study deviations and ensure timely implementation of corrective actions; - to maintain study tracking, in accordance with the demands of the study; - to monitor and update data in an Electronic Data Capture (EDC) system (where used) in a timely manner and in accordance with study specific guidelines; - to perform data management review, including in-house CRF review, and alert PMs and data managers to emerging issues with CRF completion; - to write SAE narratives to support pharmacovigilance activities if requested to; - to undertake feasibility work when required.
Clinical Research Associate (CRA)
January 2012 --- February 2014
A clinical research associate ensures compliance with the clinical trial protocol, checks clinical site activities, makes on-site visits, reviews Case Report Forms (CRFs) and communicates with clinical research investigators.
August 2010 --- January 2012
Coordinating a trial at EIO actually means managing the trial from an administrative point of view, from the first contacts with the sponsoring farmaceutical company, to prestudy visit and SIV, together with the ability of follow the ongoing trial, helping sub investigators in the compilation of CRFs and in the correct organization of all the aspects of the trial itself. As for the internal trials, my figure deals with the drafting of all the documents required for EC submission as well as manages both the correct proceeding of the trial with data collection and update creation.
December 2008 --- July 2010
Basic research on murine neural stem cell proliferation and differentiation differencies in WT and mutant (Rai-/-) cells. Also contributing to PhD program on CD133 function in human tumor neural stem cells with siRNA interference and gene reporting assays vectors creation.
Master's Degree in Cell/Cellular and Molecular Biology from Università degli Studi di Milano in 2008