Farah ZRIBI

Senior CRA at Eshmoun Clinical Research
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Contact Information
us****@****om
(386) 825-5501
Location
Sfax, Tunisia, TN

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Credentials

  • HOW TO CONDUCT GCP INSPECTIONS/AUDITS AT THE CLINICAL INVESTIGATOR SITE
    The Global Health Network
    Jan, 2022
    - Nov, 2024
  • GCP
    Boehringer Ingelheim
    Jul, 2021
    - Nov, 2024
  • Rave EDC
    Medidata Solutions
    Jul, 2021
    - Nov, 2024
  • Auditeur interne d'un système de management qualité ISO 9001:2015
    Dreams N Motion
    Dec, 2020
    - Nov, 2024
  • MySites : Site monitoring & site management using my sites
    impact.com
    Aug, 2019
    - Nov, 2024
  • ICH GCP E6 (R2)
    The Global Health Network
    Jul, 2019
    - Nov, 2024
  • Introduction to data management for clinical research studies
    The Global Health Network
    May, 2019
    - Nov, 2024
  • Introduction to collecting and reporting adverse events in clinical research
    The Global Health Network
    Apr, 2017
    - Nov, 2024
  • SPSS : descriptive and analytical statistics
    Faculté de Médecine de Sfax
    Nov, 2013
    - Nov, 2024

Experience

    • Tunisia
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Senior CRA
      • Mar 2022 - Present

    • United States
    • Technology, Information and Internet
    • 700 & Above Employee
    • Clinical research specialist
      • Nov 2020 - Dec 2022

    • Hungary
    • Biotechnology Research
    • 1 - 100 Employee
    • Clinical Research Associate/ Regulatory Affairs Specialist
      • Mar 2014 - Mar 2020

      - Monitoring activities : Preparation and conduct of site qualification, initiation, routine monitoring and close-out visits. - Study documents and tools conception. - Junior CRA training (GCPs, therapeutic area and study specific). - Project management : *Development and implementation of monitoring plan and other project plans. *Plan and oversee the site activation process. *Elaborate and update study trackers. *Client Reporting: Review and approve monitoring reports, centralization data/reports from all CRAs in all sites and mailing to the client, . -Regulatory affairs specialist: Submission to CA, training on regulatory affairs - Pharmacovigilance activities : SAEs reporting procedures, SDV, reconciliation - Patient support programs (PSP) - Quality assurance activities: Redaction and update of SOPs, organization of Audits - Data management activities : Coordination, DB cleaning, DB organization, validation plan, Data review and check, support for the processing of data queries, -Statistical analysis : conception of SAP, Statistical Analysis of study data and redaction of SAR. - CRF development : CRF and eCRF creation - Medical writing: protocol redaction, redaction of CSR, scientific articles Show less

    • Assistante en pharmacie
      • Oct 2012 - Oct 2012

  • Ecole des cadres
    • Sfax, Tunisie
    • Chargée d'enseignement de TP pharmacie galénique
      • Oct 2011 - May 2012

Education

  • Faculté De Pharmacie de Monastir
    Docteur en pharmacie, Pharmacie
    2006 - 2012
  • Faculté de Médecine de Monastir
    CEC pharmacologie et marketing pharmaceutique
    2014 - 2015

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