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Summary

CLINICAL MONITORING: Fabio is an enthusiastic CRA working assigned to a leading pharmaceutical company for Covance, since May 2015. He worked office-based as CRA from September 2013 until June 2014 in the Global Clinical Operation department of a leading pharmaceutical company initially as a trainee, and then, starting from March 2014, independently. Fabio has then moved to Quintiles, working till April 2015 as CRA home-based sponsor dedicated in a risk-based remote monitoring model. ADMINISTRATIVE ASSISTANT: Fabio worked for almost 9 years as administrative assistant within an international engineering company. He was mainly dedicated to the credit collection and the archival management, but through the years was assigned to a lot of other works, such as the accounts reconciliation, the production of technical manuals, the management of suppliers/customers' demographic data, the check of year-end warehouse stocks.

Experiences

Current Experience

  • Clinical Research Associate (CRA)
    Since May 2015
    CRA working on assignment of a major pharmaceutical company: Responsible for the support and management of study sites for Phase I/II/III clinical studies according to SOP’s, GCP regulations, local laws and regulations and protocol requirements Perform pre-trial assessment visits Assures that site personnel complete and document protocol-specific training and non-protocol-specific trainings Conducts on-going study visits. Conduct Source Document Verification of CRFs against medical records as required by SOP to ensure protocol/patient compliance Management of Visit reports, follow up letters, site communication, site management and study documentation Reports any issues to Clinical Team and ensures that site’s file is current up to date Performs drug accountability and re-labeling Responds to site requests and escalates as necessary for resolution Experience as unblinded CRA Therapeutic area: · Oncology (Melanoma) · Onco-haematology (Hodgkin Lymphoma, PMBCL) · Vaccines

Past Experience

  • Clinical Research Associate (CRA)
    April 2015 --- May 2015
    • Monitors (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations • Plans day to day activities for monitoring of a clinical study and sets priorities per site • Prepares for and conducts on-site qualification, • Monitors with knowledge of quality/scope and budget parameters • Escalates issues and feedback for the team • Works with the Clinical Manager (CM) to enhance and proactively manage site visits and trial issues during the monitoring phase • Monitors the quality of clinical deliverables and addresses quality issues with the appropriate team member • Provides accurate and timely submission of trip reports • Manages query resolution process • Assists project team with assessing project feasibility and recruitment, as applicable • Maintains project tracking system of subjects and site information as applicable • Participates in Investigators’ Meeting as designated by Project Manager • Manages investigative sites via telephone calls between visits • Ensures adherence to study timeline and budget • Attends meetings as required • May be involved in the preparation of documentation for submission to IRB/IECs and CAs as well as coordination of submission with appropriate site staff and /or Project Manager/Clinical Manager • Coaches and mentors less experienced CRAs and assist in their development and training • Acts as a resource for other CRAs and seeks opportunities to share knowledge-base and best practice • In specific projects, the CRA may be requested to also assume additional project specific responsibilities, e.g. Clinical Management for smaller or less complex studies, under the appropriate supervision of the line manager or functional lead • Other activities as designated Therapeutic area: • Rare diseases (GHD, X-linked Hypophosphatemia)

  • Clinical Research Associate (CRA)
    June 2014 --- April 2015
    Clinical Research Associate assigned to a leading pharmaceutical company: • responsible for the support and management of study sites for Phase III clinical studies according to SOP’s, GCP, local laws and regulations and protocol requirements • Assures that site personnel complete and document protocol-specific training. • Conducts on-going study visits and perform both on-site and remote monitoring activities • Management of Visit reports, follow up letters, site communication, site management and study documentation • Conduct Source Document Verification of CRFs against medical records as required by SOP to ensure protocol/patient compliance • Reports any site/subject issues to Clinical Team • Responds to site questions and escalates as necessary for resolution. Therapeutic area: oncology (lung, breast and gastric cancer)

  • Clinical Research Associate (CRA)
    March 2014 --- June 2014
    Certified clinical research associate as per Italian law (DM 15 November 2011) for maternity leave replacement - outsourced to COVANCE: • Responsible for the support and management of study sites for Phase III clinical studies according to SOP’s, GCP regulations, local laws and regulations and protocol requirements • Perform pre-trial assessment visits • Assures that site personnel complete and document protocol-specific training. • Conducts on-going study visits. • Conduct Source Document Verification of CRFs against medical records as required by SOP to ensure protocol/patient compliance • Management of Visit reports, follow up letters, site communication, site management and study documentation • Reports any issues to Clinical Team and ensures that site’s file is current up to date • Performs drug accountability and re-labelling • Responds to site requests and escalates as necessary for resolution Therapeutic Experience: vaccines, infectious diseases, osteoporosis.

  • Clinical Research Associate Trainee
    September 2013 --- March 2014
    Experience in working with senior CRAs during validation, initiation, on-going and close-out site visits to get the certification needed to perform independent monitoring activities as per Italian Law. Involved in redaction and negotiation of clinical agreements as well as in supporting start-up unit during the initial submission of clinical trials and relevant amendment to Regulatory Authority and Ethics Committees.

  • Administrative Assistant
    November 2005 --- September 2013
    Accountant assistant - Credit collection and managment of customer relationship - Built up of technical manual - Archival management - Dataentry and customer/supplier demographic management

  • Intern
    June 2011 --- July 2012
    Preparation, management and execution of miniaturized immunological microarray bioassay to develop and validate diagnostic and research laboratory protocols.

Personality

Self Assessment :
CommunicativeCollaborationAttention to detailFlexibility

Knowledge

Self Assessment :
R&DBiotechnologyCancerClinical monitoringCTMSDrug development process
LinkedIn Assessment :
BiotechnologyLifesciencesRegulatory submissionsSite ClosurePharmacovigilanceClinical trialsAssay developmentAnalytical Method ValidationEDCCTMSpharmacologyClinical DevelopmentOncology Clinical ResearchRECISTRAVELung CancerPharmaceutical IndustryCROoncologySOPmolecular biologyVaccinesValidationCancerLaboratoryR&DBiochemistryCell biologyDrug DevelopmentHealthcareInfectious diseasesBiopharmaceuticalsOncologíaBuona pratica clinicaMonitoraggio clinicoSperimentazioni clinicheRicerca clinicaNegotiationEnglishClinical Site MonitoringGCPSite InitiationSite ValidationClinical researchContract negotiationICH-GCPClinical monitoringRemote Monitoring

Education

  • Post Graduation Course in Pre-clinical and clinical drug research and development from Università degli Studi di Milano-Bicocca in 2014
  • Master's degree in Drug Biotechnology from Università degli Studi di Milano in 2012

Languages

BrightOwl Assessment:
Self Assessment:
Italian
Native
English
Professional Proficiency

Area / Region

Milan, Italy

Others

Driving License
  • Yes