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Experiences

Current Experience

  • Senior Clinical Research Associate (CRA)


    Since February 2016
    study phases: ii, iii, observational Therapeutic Areas: oncology, Neurology, cardiovascular, rare diseases Study phases: II, III, Observational Therapeutic areas: Oncology, Neurology, Cardiovascular, Rare diseases

Past Experience

  • Senior Clinical Research Associate (CRA)

    December 2014 --- February 2016
    -manage the recruitment and Qualification of assigned study sites. acted as primary liaison with participating sites. perform or collaborate in the Training of sites on study science)" rel="nofollow">Protocol, guidelines, Operations, and data submission. -monitor participating sites to ensure quality and integrity of data, site adherence to science)" rel="nofollow">Protocol, applicable gcp/ich/gep guidelines, applicable regulatory requirements, and other Documentation requirements. -ensure adherence to the science)" rel="nofollow">Protocol by review of subject consenting procedures, inclusion and exclusion criteria, Randomization procedures and blinding conditions, collection and storage of investigational product (ip), and ip accountability procedures as applicable. -independently conduct site selection visits, pre-study site visits, study initiation visits, Interim site visits, and study closeout visits according to FDA regulations and ICH guidelines, company or customer sops, as defined by the monitoring plan. -participate in the development of study-specific forms, tools, and or processes (e.g. questionnaires, case report forms, consent forms, newsletters, reports, etc.) and participate in Investigator meeting Planning in collaboration with the smc manager. Therapeutic Areas: oncology (observational studies) CNS (Phase II and Phase IV, Hospital and private practice)

  • CRA Trainee

    January 2014 --- December 2014
    - conduct monitoring visits (siv, fu, tv) to confirm science)" rel="nofollow">Protocol and ich-gcp Compliance - drug accountability and tus management - sae/erin management and reporting - perform tmf reconciliation and queries resolution - provide study status updates to team members and interaction to resolve site issues and facilitate project timelines - prepare and review Documentation for regulatory submissions - translate and verify study documents such as Clinical study synopsis and icfs - review of sops. - manage e-crf accounts and data of site/sponsor users. - support to the preparation of oncology meetings

  • Quality Control Analyst

    May 2012 --- March 2013
    physical-chemical and instrumental Analysis of raw materials and intermediates of production. Analysis of drinking water and demineralised water. use of the main Laboratory instruments: ir, gc, HPLC, ph meter and automatic titrator. continued collaboration with the departments of production and Quality Assurance. preparation for audits and inspections

  • Pharmacist trainee

    August 2010 --- February 2011
    dispensing of drugs and otc products, schedule monitoring of medicines, Inventory Management and Accounting. galenic preparations, dressing materials management and medical-surgical. skills acquired: excellent knowledge of current legislation on the sale of medicinal products and drugs.

  • Counseling student

    February 2010 --- June 2010
    guidance and counseling to students. presentation of the faculty in schools and in the halls of orientation by projecting slides and distributing information leaflets.

Knowledge

LinkedIn Assessment :
GCPClinical trialsClinical monitoringRegulatory submissionseCRFCTMSLate PhaseProblem SolvingTime ManagementMultitaskingPharmaceuticsRegulatory affairsPharmaceutical IndustryPharmacovigilanceQuality AssuranceMicrosoft OfficePharmacoeconomicsHealthcareSviluppo clinicoRicerca clinicaSOPICH-GCPoncologyCNSClinical Development

Education

  • Post-graduate course in Clinical Research Associate in from Università degli Studi di Firenze in 2014
  • Intensive General English Course Upper-Intermediate Level in English from Kavanagh College Dublin in 2013
  • MSc in Pharmaceutical Chemistry and Technology in from Università di Pisa in 2012

Training and Certification

  • Certified CRA in compliance with the Italian Ministerial Decree 15 Nov 2011 in 0000 Certification
  • License to practice as a pharmacist in 0000 Certification

Area / Region

Rome, Metropolitan City of Rome, Italy

Others

Driving License
  • No

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