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Julie HEBERT-DARBONNA

HOUILLES

En résumé

Career Summary : More than 7 years of work experience in clinical research, in several Clinical Research Organizations (CROs), as a Clinical Research Associate first (from 2006 to 2011) and then as a Study Start-Up Lead from 2011 to present.
More than 3 years of experience in Oncology.
Education in life sciences, specialization in cellular and molecular biology.

Mes compétences :
Aster
Attaché de recherche clinique
BPC
CRO
Essais cliniques
Études cliniques
Formation
ICH
International
Recherche
Recherche clinique
SGS

Entreprises

  • International CRO - Study Start Up Lead

    2013 - maintenant

  • PAREXEL International - Start-Up coordinator

    Paris 2011 - 2013 Various therapeutic fields (mainly oncology and rheumatology), various phases (phases II to IV).

    Key Responsibilities as a Study Start-Up Clinical Trial Manager:
    - to act as a lead/coordinator in order to conduct and facilitate specific start-up activities with a high accountability on quality and timelines
    - to plan/replan start-up timelines and communicate them to the international teams
    - to organize team meetings in order to train the teams on current/new processes
    - to train junior or less experienced team members
    - to conduct feasibility activities and site selection
    - to manage regulatory submissions, centrally and locally if applicable
    - to prepare/review essential documents
    - to adapt informed consents based on ICH-GCP requirements and French laws (Public Health Code, French Act dated 9 Aug 2004, Data protection Act dated 6 Jan 1978)
    - to manage Site Regulatory Packages/Investigator Initiation Packages submissions: documents collection, review and approval

    Involved in 15 study start-ups, more than 25 sites handed over to CRA for initiation visit. Involved in SOPs and department productivity improvement during a Kaizen Event in Germany.

  • PAREXEL International - Senior CRA

    Paris 2007 - 2011 Senior Clinical Research Associate
    PAREXEL International, International CRO, Paris, France

    International phase III to IV clinical trials in Oncology (hepatocarcinoma, gastric carcinoma, chronic myeloid leukemia), Urology (renal angiomyolipoma), Neurology (multiple sclerosis), Pneumology (COPD) and Rheumatology (osteoporosis). National on-site travels, international meetings and trainings travels.
    Involved in 7 clinical trials (phase III and IV), responsible for more than 30 sites. Average of 9 site visits performed by month. Participation to 4 Audits (internal and sponsor audits), no critical findings. Mentoring of junior CRAs.

    Key responsibilities as a Clinical Research Associate:

    • Operational level

    - Conduct of site selection, initiation, monitoring and close-out visits in accordance
    with ICH-GCP guidelines, SOPs, monitor guidelines and study timelines
    - Writing of site visit reports (reporting issues and taking corrective actions)
    - Training of site personnel (investigators, pharmacists, nurses) to the protocol and ICH-GCP requirements
    - Follow-up of patients/volunteers recruitment
    - Follow-up of study related documents filing according to ICH-GCP and Central Files Maintenance Plan
    - Resolution of data queries during the course of studies or database lock/interim analysis/cut-off
    - Follow-up of SAE/safety information reporting
    - Update of study databases (such as IMPACT Harmony, P-MED, CTMS)
    - Follow-up of invoicing process
    - Design of Case Report Forms
    - Design of study tools for investigator, nurses and laboratory technicians

    • Regulatory/Financial level

    - Preparation of Ethics Committee (central/local) and Ministry of Health submissions in several countries (France, Belgium, United Kingdom) : ANSM, CPP, MHRA, REC, LEC, Agence du Médicament
    - Participation to contracts establishment

  • SGS-Aster - Clinical Research Associate

    2006 - 2006 Clinical Research Associate
    SGS-Aster, exclusively Phase I clinical trials, Healthy volunteers unit, Paris, France

    National trials in several therapeutic fields phase I trials on healthy volunteers.

  • AAIOncology - International Clinical Research Associate

    2006 - 2007 International Clinical Research Associate
    AAI Oncology, French CRO specialized in Oncology clinical trials, Kremlin-Bicêtre, France

    Involved in 4 oncology clinical trials (phase II and III, breast cancer, ovarian cancer, colorectal cancer, sarcoma), international business travels (France, United Kingdom, Belgium), responsible for more than 15 sites. Average of 8 site visits per month. Participation to 1 sponsor audit, no critical findings.

Formations

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