Fernanda Ribeiro Rodrigues

Experience

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  ICF Ciências Farmacêuticas

  Feb 2011 - Oct 2016

  - Compiling records and technical reports on Bio-equivalence / Relative Bio-availability. in accordance with the legislation in force; - Compiling the scope of care at the request of technical proposal; - Technical responses to demands by the regulatory agency and monitoring done by sponsors; - Carrying out regulatory procedures and submitting clinical studies to the Ethics Committees on Research via Plataforma Brasil;- Managing Bio-equivalence studies, clinical stage, on the SINEB system (National System for Bio-equivalence Studies);- Bibliographical survey, compiling clinical pharmacology and pharmacokinetics of drugs;- Routine with the Watson LIMS and Microsiga Protheus systems;- Compiling, reviewing and training in Standard Operational Procedures; - Backup in Clinical Research studies; - Considerable knowledge of ICH E6 and E2A, GCP, FDA, EMEA and Document of Americas; - Pharmacist responsible for dispensing investigational products in Clinical Research studies. Show less - Recruitment and selection of participants in research, in accordance with the clinical study criteria;- Explanatory lectures for research participants;- Pre-internment meetings regarding the investigational product; - Booking consultation appointments; - Directing phone calls; - Assessing examinations; - Organizing, filing and monitoring laboratory clinical examinations by way of systems; - Organizing, filing and monitoring clinical files; - Registration of research participants. Show less - Recruitment and selection of participants in research, in accordance with the clinical study criteria;- Explanatory lectures for research participants;- Pre-internment meetings regarding the investigational product; - Booking consultation appointments; - Directing phone calls; - Assessing examinations; - Organizing, filing and monitoring laboratory clinical examinations by way of systems; - Organizing, filing and monitoring clinical files; - Registration of research participants. Show less

  • Clinical research analyst / bioequivalence

    Mar 2012 - Oct 2016

  • Clinical research assistant

    Nov 2011 - Feb 2012

  • Intern

    Feb 2011 - Oct 2011
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  Laboratório Teuto/Pfizer

  Nov 2016 - Aug 2017

  Regulatory affairs analyst I

  - Activities relating to post-registration of 40 products from the portfolio; - Making HMPs (Product Change Record);- Compiling PATEs (Technical Analysis Opinions);- Disposal of change control; - Analyzing DMF;- Canceling registration of presentations and medicaments; - Renewing medicament registration; - Temporary suspension of manufacture; - Analysis prioritization; - Responsible for monitoring recorded applications; - Responsible for inputting data and tracking all the company’s regulatory data through a master spreadsheet, etc. Show less

• 

  Halexistar Indústria Farmacêutica S/A

  Sept 2017 - Nov 2018

  Regulatory affairs analyst I

  Post-registration analyst, responsible for petitions of the post-registration type;- Making HMPs (Product Change Record);- Compiling PATE (Technical Analysis Opinions);- Disposal of change controls;- Analysis prioritization.

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  IQVIA

  Nov 2018 - Nov 2023

  - Developing and delivering presentations/training to sites and colleagues, as required.- SPOC CRA in important sites.- Indicated in Programm: Employee Value Proposition for “Passion” (passionate about our work and the impact we have on patients)- Performing site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice in critical studies, Phase I and II. - Buddy of CRAs and CTAs.- Ensuring all appropriate subject/patient recruitment strategies are in place at the outset of the study to maximize subject recruitment opportunities to achieve the delivery. Show less - Monitoring the therapeutics area: Neurology, Rheumatology, Hematology, Endocrinology, Infectiology and Bioequivalence studies in national and international sites (México).- Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.- If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. - 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.- Build awareness of features and opportunities of study to site.- Collaborate and liaise with study team members for project execution support as appropriate. Show less

  • Senior Clinical Research Associate - FSP Roche (Functional Service Provider)

    Jan 2023 - Nov 2023

  • Clinical Research Associate II - FSP Roche (Functional Service Provider)

    Feb 2021 - Dec 2022

  • Clinical Research Associate I - FSP Roche (Functional Service Provider)

    Aug 2020 - Jan 2021

  • Clinical Research Associate I

    Nov 2018 - Jul 2020
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  Novo Nordisk

  Dec 2023 - now

  Clinical Research Coordinator / Lead CRA

  - Support the Clinical Project Manager in the general clinical trial management tasks.- Conduct defined study management activities on allocated projects to drive the successful delivery of theproject / program according to the study management plans, under guidance of Clinical Project Manager.- Guide CRAs and advise on critical specific study issues.- Review Monitoring Visit Reports.- Management of local study meetings and local trainings.