Kristia GREMI
Opérations cliniques at MEDICAL INITIATIVES- Claim this Profile
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Français Native or bilingual proficiency
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Anglais Full professional proficiency
Topline Score
Bio
Credentials
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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 CambridgeJun, 2016- Sep, 2024 -
Formation en recherche clinique et Bonnes Pratiques Cliniques
GIRCI SOHOJun, 2021- Sep, 2024
Experience
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MEDICAL INITIATIVES
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France
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Research
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1 - 100 Employee
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Opérations cliniques
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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
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Project Manager in Clinical Operations
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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.
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Customer Service Advisor
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Aug 2021 - Aug 2021
- Cashing - Order pickup management - Customer relationship management - Cashing - Order pickup management - Customer relationship management
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Clinical Research Associate
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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
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Boulanger©
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France
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Food and Beverage Manufacturing
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Customer Service Advisor
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Jul 2020 - Aug 2020
- Cashing - Order pickup management - Customer relationship management - Cashing - Order pickup management - Customer relationship management
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Education
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University of Montpellier
Master's degree, Clinical Operations Management ans Data management -
Faculty of Pharmacy - University of Montpellier
Bachelor's Degree, Health Engineering -
University of Montpellier
Competitive Exam, First year of health studies (competitive exam for medical school and physiotherapist school)