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Facilah GENCE

WELLESLEY

En résumé

Experienced in planning and directing clinical trials for pharmaceutical industry (Boerhinger, Novo Nordisk, Amgen, Bayer, Novartis, AB Science, GlaxoSmithKline and more) and PI initiated Research Trials from inception to completion in a multidisciplinary environment in compliance with GCP, ICH and national regulations. Self motivated, looking for new challenges as a clinical research associate.

Mes compétences :
ICH GCP
Database management (EDC/RDC, IVWRS, infosario)
Ethics in clinical research
Hospital terminology

Entreprises

  • Department of Clinical Research and Innovation/Hospital Felix Guyon - Clinical Research Coordinator

    2012 - 2014 Managed 10 studies per year as per study guidelines and protocols mainly in hematology-oncology with phase II/III trials but also in a diverse collection of therapeutic indications (pediatric, diabetes, infant surgery, burn care, neonatal...) :
    - Identified and evaluated screening potential study patient via DIM list or during MDT
    - Conducted telephone interviews, scheduled study visit, scan and lab.
    - Interacted with subjects including subject education, procedural instruction, follow-up. Determined and graded of adverse events per CTCAE and get attribution from PI
    - Collected data and maintained patient information database
    - Dispensed study medication and assessed patient compliance, managed study drug shipments and clinical supplies/inventories
    - Collected, processed and shipped clinical laboratory specimens
    - Maintained a monthly tracking reports for study (tracking subject status, SAEs, protocol deviations/ problems and solutions found, and any pertinent informations)

  • Hopital Femme Mère Enfant (HFME), Lyon -  Clinical Research Coordinator

    2012 - 2012 Established a cohort of 150 patients with Idiopathic Scoliosis (IS) in order to identify genesis of IS among adolescent (include familial and sporadic scoliosis).
    - Submitted to the competent authority approval in France (ANSM) and the local IRB
    - Screened, informed consent, telephone interviews, established the patient gene tree (Cyrillic software)
    Reference peer reviewed : SA PATTEN, Patricia Margaritte-Jeannin, [...] and Patrick Edery. 2015, Functional variants of POC5 identified in patients with idiopathic scoliosis, The Journal of Clinical Investigation, 125(3):1124-1128.

  • Service d’Urologie : Clinique Mutualiste de St Etienne - Internship in Clinical Research

    2011 - 2011 Worked on different program of clinical research : PI initiated research trials, phase 3 clinical trial and a program called "Support Program for Costly Diagnostic and Therapeutic Innovations” (STIC)

    - Elaborated study documents for regulatory submission (CRF, Investigator binder and informed consent) with the project manager during one week.
    - Screened patients during MDT, input data in the CRF or EDC, informed the project manager about protocol deviations and SAE's.
    - Assisted a clinical research associate for a monitoring (elaborated monitoring Checklists, Monitored Investigator binder and CRF)

  • Laboratoire de Biochimie et Génétique Moléculaire (LBGM) - Stage de Recherche sur l’Albumine Glycquée des patients diabétiques

    2009 - 2009 Ma mission consistait à réaliser des expérimentations sur les conséquences d’une hyperglycémie au niveau du sang.

    - Objectif : Etudier les propriétés physico-chimiques de l’albumine Glycquée chez des patients diabétiques.
    - Techniques utilisées : Gel de purification,Western Blot et méthode ELISA.

Formations

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