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Emily Hu

San Francisco Bay Area

Biomedical engineer with 8+ years of hands on experience in Clinical Research and Development and Clinical Trial design, execution, and data analysis in Class 2 medical devices.

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Areas of Expertise

  • Clinical Trials

    Manages, designs, and monitors Medical Device Clinical Studies in FDA/Health Canada regulated setting.

    • Research and Clinical
    • Clinical trial design
    • Class 2 devices
    • NSR devices
    • FDA
    • PMA
    • 510(k)
    • Investigational Devices
    • GCP
    • Health Canada

My Interests

Health Sectors
Medical Devices, Biotech, Diagnostics
Markets, Health Indications, Health Issues
  • Dermatology
  • Lasers
  • Orthopedics
  • neurology
  • Orthopedic Surgery
  • Pain
  • Plastic Surgery
  • sports medicine

Experience

  • Clinical Research Engineer

    MyoScience | October 2012 - Current

    • Manages and monitors clinical studies that support FDA submissions. • Supports prototype testing at research sites & disseminate results to in-house teams. • Conducts physician training and provides device support for first-in-man prototype testing • Designs and conducts in-house research protocols that feed into new products and applications • Collaborates with the in-house clinical, R&D, and regulatory team to identify potential clinical sites for clinical trials, and develops and executes pre-clinical and clinical study activities to assure that key goals are successfully implemented. Utilizes clinical expertise to identify product requirements and communicate the field product experience and complaint reports across in-house teams. • Provides educational and training support to investigators including on-site clinical training for physicians and other medical personnel.

  • Sr. Clinical Research Associate (Consultant)

    Align Technology | August 2015 - Current

  • Clinical Project Manager

    Merz Aesthetics Inc. | January 2011 - June 2012

    • Managed and executed U.S. and Canadian clinical trials for Class II medical devices, including the development of clinical protocols, case report forms, informed consent forms, investigator manuals, product instructions for use, and study training materials; evaluation of potential investigational sites and investigators; and audit of investigational sites and investigators to ensure data integrity and protocol compliance. • Assisted with negotiating and obtaining approval for investigator agreements. • Prepared IRB submission applications and obtains IRB approvals. • Educated, trained, and supported investigators and their staff prior to and during clinical trials of investigational devices. • Managed contract monitors and data management to ensure Good Clinical Practice and data integrity.

  • Clinical Studies Manager

    LumenisSa | November 2009 - December 2010

    • Led and executed global clinical trial strategy from concept phase to publication plan for multiple Class II medical lasers and intense pulsed light (IPL) systems. Supervised clinical research associates with respect to administration of ongoing trials. • Designed and managed clinical studies including physician and site selection, protocol development, case report form (CRF) development, IRB submissions, informed consent form development, clinical site monitoring, data capture and analysis, and communication with clinical trial sites regarding all logistics. • Participated in new product development by assisting marketing group with acquiring updated information for competitive analysis and current device usage trends in new and emerging markets • Created presentation materials for international scientific symposiums and meetings. • Supervised organization of Investigator Meetings for various clinical trials. • Established positive working relationships with industry Key Opinion Leaders to facilitate current research projects, develop potential research projects, create publications, and increase podium presence.

  • Clinical Trials Associate

    Solta Medical, Inc. | August 2008 - September 2009

    • Performed clinical planning, protocol development, case report form (CRF) development, IRB submissions, informed consent form development, site selection and communication with clinical trial sites regarding all logistics including support materials and training for the development of multiple class II medical lasers and radio frequency systems. • Provided in-field clinical and technical support for clinical trials to facilitate best practices during use of the company’s medical devices in accordance with the company’s SOPs and all applicable regulations during clinical investigations and post-market studies • Collected and managed clinical data in to GCP guidelines, including facilitation of clinical image management. Reviewed and analyzed clinical trial data to facilitate completion of clinical trial reporting requirements. • Collaborated with investigator and internal team members to prepare scientific presentations and manuscripts for submission and publication for scientific journals and meetings.

  • Clinical R&D Engineer

    Solta Medical, Inc. | June 2006 - July 2008

    • Supported clinical evaluations of new lasers at key physician sites. Managed study sites and trained clinical site staff to develop protocols and ensured proper use of device as well as regulatory compliance. Performed product installations, updates, and calibration as needed. • Utilized clinical expertise to identify potential product requirements or enhancements. • Drove post-sales support to ensure successful transfer of knowledge and training materials. • Educated and trained physicians, hospital personnel, and office staff on the technical product details and therapies of non-ablative and ablative skin resurfacing laser systems in a clinical setting. • Developed educational and training materials and organized educational seminars for customers. • Provided technical, educational and sales support via one on one clinical sessions, in-service education programs, and/or seminars.

  • Lab Systems Tester

    Roche Diagnostics | December 2005 - Current 2006

  • Undergraduate Research Assistant

    UC Irvine | September 2001 - June 2003

Education

  • Duke University

    Master's | Biomedical engineering | 2003 - 2004

  • UC Irvine

    Bachelor's Degree | Chemical Engineering | 1999 - 2003

  • Jr High