Anna Carolina De Souza Catão Barros

Experience

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  Nogueira e Machado Cia de Tintas e Vernizes Ltda.

  Jan 2007 - Jul 2009

  Auxiliar de Vendas
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  Angiocardio Hemodinamica Diagnóstico e Terapêutica Ltda.

  Sept 2009 - Aug 2013

  Assistente Administrativo
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  Captativa Consultoria em Recursos Humanos

  Aug 2013 - Apr 2014

  Administrative Assistant
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  PRA Health Sciences

  Apr 2014 - May 2020

  - 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;- Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely;- Provides regular site status information to team members, trial management, and updates trial management tools;- Completes monitoring activity documents as required by PRA SOPs or other contractual obligations;- Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues;- Escalates site and trial related issues per PRA SOPs, until identified issues are resolved or closed;- Performs essential document site file reconciliation;- Performs source document verification and query resolution;- Assesses IP accountability, dispensation, and compliance at the investigative sites;- Verifies Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP guidelines;- Communicates with investigative sites;- Updates applicable tracking systems;- Ensures all required training is completed and documented;- Serves as observation visit leader;- Facilitates audit s and audit resolution. Show less · Management of activities associated with obtaining initial, amendment and other central authority approvals i.e.Regulatory Agency (RA) and Central Independent Ethics Committee(IEC);· Management of central/country level submissions associated with ensuring Investigational Product (IP) and any other clinical trial supplies can be imported and where applicable;· Management of the central/country level Informed Consent and any other documentation given to patients i.e. diaries, questionnaires through to submission and approval by country level RA and Central IEC as appropriate;· Tracking and reporting of central submission/approval progress in Clinical Trials Management System (CTMS), eTMF and other applicable PRA systems;· Perform role of Local Reviewer in the QC process as appropriate;· Providing consultancy to the client on any country specifics issues if requested by the Start-Up Lead (SUL), GRAL, Clinical Team Manager (CTM) or Project Manager (PM);· Supporting the Senior level Regulatory staff/Country Consultant in the maintenance of the accurate, up to date Country Knowledge Repository;· Attending internal and external project team meetings as determined by the GRAL, SUL, CTM or PM;· If applicable for the Country, submit expeditable safety reports to RAs and central IECs in accordance with relevant legislation and the project-specific contractual agreement;· Any other duties deemed necessary to secure the success of PRA’s business;· Support Business Development opportunities by providing regulatory input on assigned RFPs, RFIs and BDMs;· Contribute to the maintenance and collection of Regulatory Intelligence by ensuring that tools such as the Country Knowledge Repository and the Country Fact Sheets are up to date; communicate new information or changes to the Regulatory Intelligence Consultant team;· May work with GRA team members to provide Regulatory consulting services. Show less • Generate and maintain databases for appropriate study administration;• Prepare and perform a periodic review of the Trial Master File (TMF) including all GCP-related documents;• Prepare study site files, review for accuracy and completeness, and send to sites prior to study initiation visits;• Administer all study and related documents before and during the course of the study (i.e. drug accounting documents, correspondence, monitoring reports, contact reports, and other organizational papers);• Support PM and/or Clinical Research Manager, CRAs, Start Up, and Regulatory Teams in all start up activities, as required;• Assist PM and/or Clinical Research Manager to prepare project status reports for the Sponsor;• Responsible for documenting, finalizing and distributing all project team/Sponsor meeting minutes and agendas;• Order and track Clinical, Non-Clinical Supplies and shipment of Investigational Product (IP) for sites;• Assist PM with tracking Feasibility Status (i.e. Investigator Site Selection activities);• Track study enrollment logs and provide the updates daily to the assigned PM and/or Clinical Research Manager, as required;• Update all study related logs (i.e. Enrollment Logs, Frequently Asked Questions, etc.) and distribute them to the CRAs as requested by the assigned PM and/or Clinical Research Manager;• Forward clinical trial documents including but not limited to agendas, meeting minutes, telephone contact reports and monitoring visit reports to be filed within the Trial Master File (TMF);• Routinely forward batched copies of all final trip reports (i.e. electronically via email and/or hard copy) to the Sponsor as indicated per the Project Team’s Monitoring Plan;• File and audit all study-related documents;• Contact sites as requested by the PM and distribute study related information to the Regional CRAs;• Ensure timely and accurate study related communication is distributed to the clinical study team. 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  • Clinical Research Associate I

    May 2018 - May 2020

  • Regulatory Affairs Specialist I

    Jun 2016 - Apr 2018

  • Clinical Trial Assistant

    Apr 2014 - May 2016
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  The Janssen Pharmaceutical Companies of Johnson & Johnson

  May 2020 - now

  • Specialist Clinical Research Associate

    May 2023 - now

  • Senior Clinical Research Associate

    Apr 2021 - Apr 2023

  • Clinical Research Associate II

    May 2020 - Mar 2021