Experience

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  Enthalpy analytical

  Jul 2019 - Jul 2020

  Toxicology technician i
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  Goldbelt c6, llc

  Jul 2020 - Aug 2021

  Microbiologist
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  Virginia department of general services

  Dec 2021 - Apr 2022

  Newborn screening scientist 1
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  Virginia commonwealth university

  Apr 2022 - now

  - Focusing on regulatory aspects of Industry, NIH, FDA, and investigator-initiated studies during the start-up, continuing review period, and closure procedures for Phase 1, 2, and 3 clinical trials.- Managed regulatory submissions including preparing and submitting documents to the local and central IRBs (Advarra and WIRB) throughout the study start-up, continuing review and study close-out.- Monitored and oversaw our team’s regulatory compliance to ensure clinical trials adhered to GCP/ ICH/ FDA, and HIPAA regulations and guidelines.- Developed and maintained SOPs to ensure regulatory compliance was being followed across our clinical trials.- Prepared and maintained regulatory files ensuing all necessary documentation was up to date and compliant with regulations—utilizing various eTMF systems—RedCap, Veeva Vault, OnCore, and Anju—and physical Investigator Site File Binders.- Coordinated communication, in a timely and accurate manner, with CRO/ Sponsors and regulatory authorities for scheduling monitor visits, study start up visits, close out visits, and audits as needed.- Knowledge in utilizing multiple data capture/retrieval systems and working with the health care system to deliver, track, evaluate, collect and submit subject data. As well as navigating EMR systems, EPIC, Cerner, OnCore, Veeva Vault, RedCap, Fountayn, Medidata RTSM/EDC/IRT.- Lead study coordinator on multiple studies, while ensuring good documentation practices, communicating all AEs/SAEs, protocol deviations, data capturing and any regulatory document review/updates.- Trained and mentored junior clinical research staff. Show less

  • Clinical Research Coordinator II/ Clinical Research Regulatory Coordinator I

    Jul 2023 - now

  • Clinical Research Coordinator I

    Apr 2022 - Feb 2024