Ines Turner - Operations Manager Resume Simple
SUMMARY
I am a highly motivated, detail-oriented professional with over 10 years of experience in the healthcare industry. I have a strong background in the medical field.
SKILLS
  • management, regulatory affairs, clinical trial, records management, clinical
  • clinical
WORK EXPERIENCES
  • 2017-12-252017-12-25

    Operations Manager

    Eastern State Hospital

    • Provide clinical trial management for investigational sites and ensure adherence to all regulatory requirements and HIPAA regulations. Maintain and update the study specific files.
    • Lead the TMF team to ensure that all regulatory documents are compliant with cGMP and ICH guidelines and 21 CFR 820.
    • Review and approve all regulatory documents for submission to the IRB, including the approval of the study Master files, TMF and the appropriate documentation.
    • Assist in the development of the study Master file (TMF) for the TMF and in house management. Review and approve regulatory documents for completeness and accuracy.
    • Monitor the regulatory documents and ensure the TMF is up to date on all relevant documents in the TMF. Provide training to the site staff in compliance with GCP guidelines.
    • Review and approve regulatory documents for submission to regulatory authorities. Assist in the development of protocols and amendments. Ensure that all study related documents are complete and accurate.
  • 2017-12-252017-12-25

    Regulatory Affairs Assistant

    Schering Plough

    • Review and approve regulatory documents for submission to the FDA. Ensure that all regulatory submissions are submitted to the FDA.
    • Provide regulatory guidance to the investigational sites to ensure that the trial is in compliance with the FDA regulations. Manage the preparation of the submission documents for the FDA.
    • Review clinical data for accuracy and completeness, and ensure that all study documents are complete and accurate. Ensure that all regulatory documents are up to date.
    • Knowledge of FDA regulations, ICH guidelines, and other regulatory requirements. Ensure that all regulatory documents are current and current.