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Nina SAMO

Princeton

En résumé

I'm looking for a new opportunity and I would like to work within a CRO or a pharmaceutical company.
Available, autonomous, rigorous and with good interpersonal skills, please do contact me for current or future opportunities within your company.

Mes compétences :
Clinical Research
Cosmetics
Food
Innovative
Management
Management Development
Médical
Medical devices
Microsoft Project
Microsoft Project Management
Nutrition
Nutrition and Health
Products
Research

Entreprises

  • Covance - CRA

    Princeton 2015 - maintenant CRA home-based in Germany

  • Hôpital raymond poincaré, garches - Clinical trial technician

    2013 - 2014

  • Hopital Robert Debré (Paris) - Clinical Research Associate

    2011 - 2012 Clinical Research Associate, Hôpital Robert Debré (Paris)
    Centre de Références maladies endocriniennes rares de la croissance.

    Pharmaco-epidemiology studies on Growth Hormon (phase IV)

    • Constitution of a national cohort of patients with endocrine diseases
    • Setting up and managing the database CEMARA within the national network centers and queries management
    • Management of a multicentric study, spread over 28 national centers
    • Initiation and on-site monitoring visits
    • Using of e-CRF and paper CRF
    • Drafting of visit reports and weekly meeting with the head project
    • Permanent contact with all the investigators

  • Hopital Robert Debré (Paris), Unité de Recherche Clinique - Clinical Research Associate

    2011 - 2011 Clinical Research Associate,
    Unité de Recherche Clinique, Hôpital Robert Debré (Paris),
    Therapeutic areas : Immunology, hematology, metabolic disorders
    • Review of Protocol, CRF and other studies documentations
    • Creation and update of the TMF and other study files
    • Initiation, on-site monitoring visits and close-out of investigational sites.
    • Using of e-CRF and paper CRF
    • Drafting of visits reports
    • Using of GCP and ICH guidelines

  • Intertek 4-Front Research SAS (CRO) - Clinical Research Associate

    2010 - 2010 Study management of trials based on Dermo-cosmetics and medical Devices
    • Documents Review: protocol, CRF, Informed Consent Forms,
    • Creation and update of TMF
    • Initiation, centralize monitoring, data cleaning, and close-out of studies
    • Drafting of studies report.
    • Permanent contact with the sponsors
    • Submission of protocol and consent documents to AFSSAPS and local EC for a phase II study based on a medical device.

    • Using of GCP and ICH guidelines

  • Pôle Technologique CASIMIR - Project Manager Assistant on health Nutrition

    2009 - 2009 Accompanying the food industries of the region Auvergne in their projects:
    • Development of new products, improving existing products.
    • Meanwhile, health-nutrition watch (scientific, technological, regulatory and competitive watch).
    • Drafting of newsletters

    Under the responsibility of project manager nutrition, my mission was to:
    - seek for relevant information,
    - find solutions
    - make a nutritional diagnosis: analysis of the nutritional composition, impact of industrial processes
    - propose ways of improving the nutritional quality of products
    - find the potential suppliers

    Outcomes:
    • Optimization of existing products
    • Formulation of new products
    • Development of nutritional communication, by using nutritional claims.

  • Laboratoire municipal de Toulon - Quality Assurance

    2008 - 2008 Internship in Quality Assurance.
    Sample registration
    Preparation of media analysis
    Traceability and verification of test results.
    Respect of GLP and NF / EU.

Formations

  • Université Strasbourg 1 Louis Pasteur

    Strasbourg 2010 - 2011 DIUFARC TEC : Clinical Research Associate Training

    Law on biomedical research, GCP, ICH Guidelines,
    Clinical trials documents (protocol, investigator brochure, CRF, TMF...)
    Role of the CRA
    Responsibilities of the sponsor and investigator
    information and patient consents
    Report of serious adverse events
    pharmacovigilance.

  • Université Clermont 1 Auvergne (Clermont Ferrand)

    Clermont Ferrand 2009 - 2010 Master 2 Chef de projet en Développement de produits pharmaceutiques

    Project management, health nutrition, clinical research, drug development, Marketing, communication, economy and business management, informatic tools (MS Poject)

  • Université Clermont 1 Auvergne (Clermont Ferrand)

    Clermont Ferrand 2008 - 2009 Master 1 Nutrition et Sciences des Aliments

    nutrition, food sciences,
    metabolic pathology (diabetes, hypercholesterolemia, obesity, cardiovascular diseases);
    link between health and nutrition
    link beween nutrition and cancer;
    food supplements

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