Experience

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  North dallas research associates

  Mar 2012 - Mar 2016

  Clinical research coordinator

  - Clinical study management of Phase 3 or Phase 4 drug trials- Implementation of the Site’s SOP- IRB reviews and submissions of various studies- Sponsor case reporting - Data entry including extensive training on In-Form, CIRT, and various eCRFs portals - Perform on site visits and generate visit/contact reports in accordance with the monitoring plan - Management of Investigational Product (medication or devices) to include inventory, dispensing, and electronic data systems reconciliation. - Update all relevant tracking system on an ongoing basis - Monitor patient safety on-site (review for missing SAEs, AEs, ConMed) and address protocol violations - Study timeline management in accordance with study protocol time frame - Monitor and maintain compliance with regulatory agencies and study specific procedures - Inform responsible CRA Coordinator/COL/Manager of work status on a biweekly basis- Complete routine administrative tasks in a timely manner (e.g. time sheets, metrics, and health records requests) - Recognize out of scope activities, escalate and communicate to the CRC or PI - Take responsibility for specific tasks on projects, or acts as the main CRA contact on individual projects - Function as a training coordinator for new team members to ensure study specific training - Conduct on-site study-specific training (if applicable) - Adult and Geriatric blood draws and lab requisitions - Patient standard of care and research related appointment maintenance and reminders- Patient education coordinator upon implementation of new protocol or changes in study design- Patient compensation and disbursement Show less

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  Baylor scott & white health

  Mar 2016 - now

  Clinical research coordinator

  Clinical research coordinator to Dr. William C. Roberts.

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  Baylor heart and vascular hospital

  Mar 2016 - now

  Clinical research coordinator