Franck Cerqueira, MsC

Experience

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  Farmácia da Barranha

  May 2009 - Feb 2012

  Lic. Farmácia
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  .Blueclinical

  Sept 2012 - Jun 2014

  Clinical Trial Assistant

  - Comply with overall study time lines to maintain recruitment progress, data cleaning and appropriate data management- Review of clinical trial processes;- Assure compliance with all protocol requirements- Document and track the resolution of all outstanding site-specific protocol-related issues from visit to visit- Report Adverse Events and Serious Adverse Events and follow up- Preparation of the submission dossier of the clinical study

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  Sponsor dedicated

  Aug 2014 - Jun 2019

  Clinical Research Associate

  Function including overall assessment of clinical trial development - oncology (small lung cell cancer) and rheumatoid arthritis :- coordinate feasibility requests;- prepare submission documentation;- organization and preparation in sponsors visit (e.g. qualification, initiation of the site, monitoring, etc):- opening visit: randomization screening, clinical team breefing;- follow-up visit: evaluation of feasibility, assessment of implementation of ICH-GCP norms and compliance with SOPs;- closing visit: close-out of technical folder, arquive and submission of dossier to regulamentar authorities (CEIC, INFARMED);- Collection, recording and processing of clinical data;- Update and management of documents and files required for clinical trials. Show less

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  Medpace

  Jul 2019 - Mar 2021

  Clinical Research Associate / Regulatory Submissions Coordinator DUAL ROLE

  - Conduction of qualification, initiation, monitoring, and closeout visits;- Communication with the medical site staff;- Verification of adequate investigator qualifications, training, and resources;- Review and Verification of Source documents and data;- Review of medical device and/or investigational product/drug accountability and inventory;- Review and Verification of patient safety data and its timely reporting;- Support sites with their patient enrollment and retention challenges;- Completion of monitoring reports and follow-up letters Show less

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  Escola Superior de Saúde do Porto

  Sept 2019 - Feb 2020

  Invited Assistant Professor

  Pharmacology and TherapeuticsI&D of New Drugs and Health ProductsBiopharmacy and PharmacokineticSimulated Practice of Pharmacotherapy III

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  Springer Nature

  Feb 2020 - now

  Editorial Reviewer for Therapeutic Innovation & Regulatory Science

  Peer reviewer of articles for Therapeutic Innovation & Regulatory Science journal, Springer Nature Publishing Inc.

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  Labcorp

  Mar 2021 - May 2023

  • Senior CRA I - Sponsor dedicated

    Nov 2022 - May 2023

  • Clinical Research Associate II - Sponsor dedicated

    Mar 2021 - Nov 2022
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  MSD Portugal

  May 2023 - now

  Senior Clinical Research Associate