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Canale MARIO

MALAKOFF

En résumé

Presently I am Study Coordinator at Saint Joseph Hospital in Paris. During the past 4 years I have acquired extensive experience in clinical research by collecting and managing study data in the field of oncology.
Now,I am particulary interested in working in an international clinical research organization or in a pharmaceutical company that will provide me with an environment for career growth and opportunities for further development of my skills.

Mes compétences :
Clinical Research
CRO
Reliable
Research

Entreprises

  • Hopital saint joseph-oncologie - Attaché de recherche clinique

    maintenant 2006 to present: Hospital CRA-Oncology-Saint Joseph Hospital, Paris 75014
    Thorough knowledge of ICH guidelines and GCP
    International phase I to IV clinical studies:
    Lung, urology, gynaecology, senology, gastroenterology and supportive care
    Clinical monitoring (patients pre-screening, CRF completion, Queries resolution,SAE notification)
    Use of eCRF
    Logistics management studies
    Organization of visits and the follow up of patients enrolled
    Study file maintenance
    Participation in on site medical meetings (patient screening)
    Participation in international sponsor Investigator meetings
    Organization of internal meetings (status of ongoing studies, reminder of investigator’s role and duties, presentation of the new projects)
    Management of hospital financial agreements and investigator contract, hospital extra costs negotiation
    External audit (5 studies audited: no major deviation found)
    Training of nurse staff and of 5 CRAs on clinical studies
    Creation of worksheets and study tools
    Internal auditor- organization of the cares and quality service
    Assessment, report, solutions’ suggestion, action plan monitoring

    1985 to 2006: Laboratory technician - Biology laboratory - Saint Joseph hospital, Paris 75014
    Management of blood samples for RIA analysis and molecular biology
    Blood sampling of external patients

Formations

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