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Maeva ROQUES

MONTRÉAL

En résumé

Pas de description

Entreprises

  • Scimega Research - Program Specialist (Clinical operations oversight)

    2020 - maintenant
  • Scimega Research (Montreal, Canada) - Clinical Trial Leader

    2016 - maintenant Site selection and study start-up activities
    o Organize site start-up activities
    o Review investigator contracts and budgets
    o Attend investigator meetings

    Study management and maintenance of client relationships
    o Organize periodic meetings with our clients
    o Prepare and distribute periodic progress reports to clients
    o Identify potential risks to the conduct of the study and pro-actively identify mitigating actions

    Supervision of Scimega CRAs
    o Plan and organize initial training for newly hired CRAs
    o Ensure that all CRAs are adequately trained at all phases of the project.
    o Conduct periodic meetings with the CRAs to discuss the progress of each trial
    o Review site visit reports and follow-up letters
    o Act as support for junior CRAs and conduct co-monitoring visits

    Site management
    o Conduct investigational site selection, initiation, routine monitoring and termination visits
    o Monitor study centers in accordance with International Conference on Harmonization Good Clinical Practice (ICH GCP)and Sponsor SOPs
    o Serve as liaison between the Sponsor and the Investigator
    o Account for study drug storage, study drug usage, including reconciliation and destruction
    o Review the Investigator Study Files as required to maintain them up-to-date and accurate
    o Review adverse events for accurate recording and reporting
    o Submit written reports following site study visit
    o Act as a resource for investigational site queries
    o Participate in project team meetings and conference calls

    http://scimega.com/
    We are a Canadian specialty CRO with a singular focus on oncology. We play a vital role in improving the speed and efficiency of oncology clinical research through a deep understanding of the needs of sponsors, investigators and patients.
    Our mission is to attract cutting-edge oncology compounds and clinical trials to Canada by improving site selection and patient recruitment, and accelerating the conduct of oncology clinical trials.
  • Scimega Research (Montreal, Canada) - Senior Clinical Research Associate, Oncology

    2015 - 2016 • Study start-up activities
    • Conduct investigational site selection, initiation, routine monitoring and termination visits
    • Monitor study centers in accordance with International Conference on Harmonization Good Clinical Practice (ICH GCP)and Sponsor SOPs
    • Serve as liaison between the Sponsor and the Investigator
    • Account for study drug storage, study drug usage, including reconciliation and destruction
    • Review the investigator file as required to maintain up-to-date and accurate the Investigator Study Files
    • Review adverse events for accurate recording and reporting
    • Submit written reports of investigation site findings following site study visit
    • Act as a resource for investigational site queries
    • Review investigator contracts
    • Act as support for junior CRAs

    http://scimega.com/
  • Scimega Research - Clinical research associate

    2012 - 2015 www.scimega.com
  • LA-SER Group - Clinical research associate

    2011 - 2012
  • ICTA PM - Attachée de recherche clinique

    CHALAIS 2009 - 2011
  • New England Biolabs - Stagiaire en recherche

    2008 - 2009 Stage de 8 mois en recherche fondamentale dans la division ARN. Projet: développement de nouveaux outils pour la localisation d'ARNm dans des cellules de mammifères

Formations

Réseau