Fabio Moraes

Experience

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  Boehringer IngelheimSão P

  May 2009 - Apr 2011

  Clinical Research Trainee

  Translation, revision and adaptation of essential documents (Trial Protocol, Informed Consent Form, Patient Information Sheet, Investigator Brochure).Collection of documents from investigators’ sites (Confidentiality Agreement, Site Feasibility Questionnaire, Financial Disclosure Questionnaire).Assembling of ethical and legal dossier (CEP/CONEP and ANVISA).Preparation of final reports to legal authority (ANVISA).Conduct of importation processes and logistical control of Investigational Product and trial supplies.Clinical Trial Master File (CTMF) maintenance and quality control Show less

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  PPD

  Apr 2011 - Aug 2014

  Project Assistant

  Support to the trial team members in Brazil and ColombiaUpdate trial-related information in the Clinical Trial Management System (CTMS).Preparation of partial and final reports to ANVISAAssembling, maintenance and audit of electronic and physical Trial Master File and Investigator Files.Transfer of files to the sponsor during the conduct of clinical trials and after trial close-out. Training Project Assistants in Latin America on client-specific SOPs and process-specific requirementsCo-monitoring visits with CRAs Show less

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  Parexel

  Sept 2014 - Mar 2022

  • Associate Project Leader

    Feb 2021 - Mar 2022

  • Senior Project Specialist

    Nov 2018 - Feb 2021

  • Project Specialist 2

    Nov 2016 - Nov 2018

  • Project Specialist

    Sept 2014 - Nov 2016
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  Syneos Health

  Mar 2022 - Jul 2023

  Project Manager II
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  ICON plc

  Jul 2023 - now

  Project Manager