Experience

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  LimFlow SA

  • France
  • Medical Equipment Manufacturing
  • 1 - 100 Employee

  • Director Clinical Affairs

    • Sep 2022 - Present

  • Manager Clinical Affairs

    • Mar 2018 - Nov 2022

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  Element Science, Inc.

  • San Francisco Bay Area

  • Senior Clinical Specialist

    • May 2017 - Mar 2018
    • San Francisco Bay Area

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  Claret Medical

  • Santa Rosa, CA

  • Sr. Clinical Research Associate

    • May 2015 - Jun 2017
    • Santa Rosa, CA

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  Optiscan Biomedical

  • Medical Equipment Manufacturing
  • 1 - 100 Employee

  • Clinical Research Associate II (CRA II)

    • Feb 2015 - May 2015

  • Clinical Research Associate I (CRA)

    • Jan 2014 - Feb 2015

    - Design, plan and execute clinical trials. Design and implement electronic data capture (EDC) systems, Case Report Forms and specific study tools. Manage the activities of Research Associates, study investigators, site coordinators, clinical research organizations (CROs), contractors, and regional monitors. Oversee and ensure compliance with study protocols, FDA and International regulations, IRB and/or EC requirements and overall clinical objectives.- Currently assisting in managing our pivotal U.S. clinical trial, known as MANAGE IDE including participating in four site initiation visits, contract agreements, IRB approvals, monitoring activities, data collection and site correspondance.

  • Research Associate/Clinical Support

    • Jan 2011 - Jan 2014

    • Led and organized a BSLII laboratory. Wrote, reviewed and executed protocols. Maintained and performed QC tests on various chemistry analyzers including YSI 2300, ABL Flex, and AU 480. Operated the Nicolet 6700 FTIR, Sartorius microbalance, pH meter, and microscope. Organized and collected data, wrote reports, and presented findings to senior management. Performed weekly inventory and ordered supplies. • Chosen to prepare and begin a $2+ million clinical trial at AMC hospital in Amsterdam, The Netherlands; worked closely with the PI and research nurses to gather data, train, plan, and comply with GCP guidelines. Generated all necessary documentation for regulatory filing, and analyzed machine performance.• Initiated a turn-point clinical study at Erasme Hospital in Brussels, Belgium; Trained the PI, sub-PIs, clinical coordinator and research staff on the study protocol, procedures, equipment, CRFs, and work flow. Created relationships with the medical staff. Performed an in-service to a globally recognized company who later invested in the company.• Led, monitored, and characterized machine performance across five animal testing experiments.• Kept detailed records of data findings, observations, and conclusions. Created a library of frozen clinical laboratory samples

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  Childrens Hospital Oakland

  • San Francisco Bay Area

  • Volunteer

    • Nov 2010 - Jan 2011
    • San Francisco Bay Area

    Established a comfortable atmosphere and provided support for patients and their families. Greeted patients and passed on warming smiles.

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  John Muir Health

  • Radiology/Oncology Dept Volunteer

    • Mar 2010 - Jan 2011

    • Provided support to the nursing staff, technicians and oncology coordinator. Welcomed new patients to the clinic. Entered medical data into a database.• Organized and filed paperwork. Created welcome folders for new patients starting radiation treatment • Assisted nurses in gathering patient information while strictly adhering to HIPAA guidelines