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Delphine MAYEKO

Slough

En résumé

Mes compétences :
Biotechnologies
Coordination
CRO
Études cliniques
GCP
Guidelines
ICH
monitoring

Entreprises

  • Chiltern International - Clinical Team Leader/ Clinical Project Leader pour Genzyme - Sanofi

    Slough 2012 - maintenant
  • Chiltern International - Senior Clinical Research Associate pour Genzyme

    Slough 2011 - 2012
  • DOCS - Senior Clinical Research Associate pour Johnson&Johnson

    2010 - 2011
  • CLINACT - Clinical Research Associate trainee

    2006 - 2006 - Managed two epidemiological studies.
    - Monitored by phone: sites selection, initiation, follow-up.
    - Managed essential documents of the studies: Sites financial contracts, patient questionnaires, and investigators invoices.
    - Managed assigned sites by regular contacts to ensure site compliance, adequate enrollment, and understanding of study requirements.
    -Transversal project: “Psychiatric specificities in Clinical Research”
    Selected Psychiatrists involved in Clinical Research.
    Performed visits and interviews supported by a questionnaire written by the team.
    Reported to project team all minutes.
    Prepared the report.
    Gave a presentation in English.
  • I3 Research - Clinical Research Associate

    2006 - 2010 - Performed routine site visits, including pre-study, initiation, interim, and closeout visits. Visits to include monitoring of proper informed consent procedures, compliance with protocol, GCP/ICH Guidelines, and other applicable regulatory requirements, and assurance of good site performance.
    - Managed assigned sites by regular contacts to ensure site compliance, adequate enrollment, and understanding of study requirements.
    - Reported to company project team, client, and site personnel any findings noted at monitoring visits.
    This was accomplished by completion of monitoring reports and follow-up letters within the project- specific timelines.
    - Trained study team members on a specific electronic CRF application
    - Participate in vendors set-up activities
    - Maintained project tracking systems of activities, subject and site information.
    - Participated in feasibility studies.
    - Participated in regulatory and contract set-up activities
    - Participated in company-required training programs.
    - Performed necessary administrative functions (e.g., tracking of expense reports, time and attendance).
    - Performed other duties as assigned.
  • Aster Céphac - Study Nurse

    2005 - 2005 - Phase I only
    - Reported data in CRFs in collaboration with
    investigators.
    - Performed ECG, holters.
    -Took blood pressure and blood samples.

Formations

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