Kristia GREMI

Opérations cliniques at MEDICAL INITIATIVES
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Contact Information
Location
FR
Languages
  • Français Native or bilingual proficiency
  • Anglais Full professional proficiency

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Credentials

  • LanguageCert Level 2 Certificate in ESOL International (Listening, Reading) LanguageCert Test of English C1
    LanguageCert (PeopleCert Qualifications Ltd)
    May, 2022
    - Sep, 2024
  • Cambridge English Certificate (CEC) - B1 Pass
    University of Cambridge
    Jun, 2016
    - Sep, 2024
  • Formation en recherche clinique et Bonnes Pratiques Cliniques
    GIRCI SOHO
    Jun, 2021
    - Sep, 2024

Experience

    • France
    • Research
    • 1 - 100 Employee
    • Opérations cliniques
      • Sep 2022 - Present

      - Activités terrain : Site management ; Mise en place, monitoring et clôture de centres d’investigation.- Activités de gestion de projet : Faisabilité et sélection de centres ; Rédaction et relecture de documents d’étude (protocole, consentement, CRF…) ; Soumission réglementaire ; Rédaction de procédure spécifique d’étude ; Planification et mise en place d’outil de gestion de projet; Coordination avec le pôle biométrie (queries, data review, gel de base et rapport statistique); Rédaction/relecture de rapport clinique ; Initiation des devis client et des prestataires ; Gestion globale de projet (réunions hebdomadaires)- Participation au renforcement du système qualité interne (rédaction/relecture de procédures)- Participation présentation réglementaire mensuelle en interne

    • Project Manager in Clinical Operations
      • Jun 2022 - Aug 2022

      - Activities: Co-management of a clinical research project; involvement in the drafting of study documents, regulatory submissions, monitoring... Participation in the revision of internal procedures (quality system) and participation in regulatory monitoring.

    • Customer Service Advisor
      • Aug 2021 - Aug 2021

      - Cashing - Order pickup management - Customer relationship management - Cashing - Order pickup management - Customer relationship management

    • Clinical Research Associate
      • Jun 2021 - Jul 2021

      - Training in Good Clinical Practices (SoBPC by GIRCI SOHO) - Staffing and screening of patients in the department, to establish their eligibility for ongoing studies - Included-patients' follow-up and collection of data of interest - Writing of a scientific article on the consent procedure for minors in clinical research - Training in Good Clinical Practices (SoBPC by GIRCI SOHO) - Staffing and screening of patients in the department, to establish their eligibility for ongoing studies - Included-patients' follow-up and collection of data of interest - Writing of a scientific article on the consent procedure for minors in clinical research

    • France
    • Food and Beverage Manufacturing
    • Customer Service Advisor
      • Jul 2020 - Aug 2020

      - Cashing - Order pickup management - Customer relationship management - Cashing - Order pickup management - Customer relationship management

Education

  • University of Montpellier
    Master's degree, Clinical Operations Management ans Data management
    2022 - 2024
  • Faculty of Pharmacy - University of Montpellier
    Bachelor's Degree, Health Engineering
    2020 - 2022
  • University of Montpellier
    Competitive Exam, First year of health studies (competitive exam for medical school and physiotherapist school)
    2018 - 2020

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