Giovanni Fausti, PhD

Experience

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  Farmacia Zanobini

  Sept 2011 - Dec 2011

  Stage Pharmacy

  During three months, as warehouse worker and sales clerk in a pharmacy in Florence. Opportunity to learn about drugs dispensation, sales and storage.

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  ENSICAEN - Ecole Nationale Supérieure d'Ingénieurs de Caen

  May 2013 - Jul 2013

  Research Internship, Pharmaceutical Chemistry

  During three months, Erasmus Program between the University of Florence and University of Caen. I worked in the group CALYPSO of laboratory LCMT of Caen, for the development of new synthetic methodologies for the formation of enantioenriched phosphine-boranes.

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  University of Caen, Basse Normandie

  Jan 2014 - Jul 2017

  PhD Organic Chemistry

  Metal-free Photocalyzed Hydrofunctionalizations by using different phosphorus-nucleophiles and substrates.

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  IQVIA

  Feb 2017 - Jul 2019

  Perform site monitoring, selection, pharmacy, remote and close-out visits in accordance with contracted scope of work and good clinical practice. Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas. Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Project Manager (CPM), Clinical Lead (CL), Quality Manager (QM) and/or Line Manager (LM). Manage the progress of assigned studies by tracking regulatory submissions and approvals, following and boosting recruitment and enrollment, reviewing Informed Consent Forms (ICFs) and eligibility criteria, following up electronic Case Report Form (eCRF) completion and submission, managing Serious Adverse Events (SAEs), reviewing Investigator Site File (ISF) by keeping it compled and updated, and managing data query generation and resolution. Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regularManage and help to conduct Audit at site to assess monitoring activities and site monitoring performance. Show less

  • Clinical Research Associate I

    Oct 2017 - Jul 2019

  • Clinical Research Associate Trainee

    Feb 2017 - Sept 2017
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  PRA Health Sciences

  Jul 2019 - May 2021

  Clinical Research Associate II

  Providing services for Novartis France.Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines.Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites.Completes monitoring activity documents as required by PRA SOPs or other contractual obligations.Verifies Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP guidelines.Ensures all required training is completed and documented.Communicates with investigative sites.Assesses IP accountability, dispensation, and compliance at the investigative sites.Performs source document verification and query resolution. Show less

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  ICON plc

  Jun 2021 - now

  Acting as functional lead from clinical operations with oversight of, and overall accountability for site selection, site initiation, patient recruitment, site monitoring, data retrieval and study close-out.Responsible for risk monitoring strategies, associated action plan and issue resolution and contributions to the cross-functional project management plans.Overall responsibility for managing the clinical operations project team and ensuring compliance with ICON SOPs, study contracts, budgets and quality standards. Show less Responsibilities include identification, selection, initiation, and close-out of appropriate investigational sites for clinical studies. Monitor those sites in order to ensure that studies are carried out according to the study protocol, ICON SOPs/WPs, applicable regulations and the principles of ICH-GCP.Involvement, when required, in other areas of study management and staff training and contribute to the review of ICON systems and procedures, as appropriate.Coaching and mentoring of monitoring competence to inexperienced/less experienced colleagues.Contribute to the culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs. Recognize, exemplify and adhere to ICON’s values which center around a commitment to People, Clients and Performance. Show less

  • Clinical Trial Manager

    Dec 2022 - now

  • Senior Clinical Research Associate

    Jun 2021 - Dec 2022