Ted May

Experience

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  Jean Brown Research

  Jul 2014 - Apr 2017

  Recruitment, screening, and management of Clinical Research trials. Duties include; Protocol compliance and review, Conducting the consent process and study specific visits with subjects, collecting and reporting Adverse Event and Serious Adverse Event information as required. Assisting the Principal Investigator in ensuring safety of subjects and maintaining communication with trial sponsors. Responsible for original source documentation, electronic data entry, and upkeep of regulatory documents as required. Show less

  • Quality Control Coordinator

    Sept 2016 - Apr 2017

  • Clinical Research Study Coordinator

    Sept 2014 - Apr 2017

  • Research Assistant

    Jul 2014 - Sept 2014
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  Intermountain Healthcare

  Apr 2017 - now

  Key management role in the development and execution of multiple clinical trials, including a system-wide genetic population study with over 200,000 enrollments. Supervising adherence to GCP/ICH guidelines and facilitating staff training and mentorship with a focus on ALCOA-C compliance. Manages the development of EDC databases, source documentation, and study teams at multiple sites across Utah . Leads cross-functional teams to successfully execute system-wide projects and initiatives including Electronic Consenting in multiple languages, development of a genetic return of results process, and overcoming regulatory barriers to achieve study goals. Collaborates with investigators and tracks study progress from site initiation to study close-out to ensure that study budget, milestones, and enrollment goals are met in a timely and efficient manner. Works in synergy with data analysts and IT professionals to ensure the accurate development of study databases. Develops, quality checks, and deploys solutions tailored to the requirements of sponsored clinical trials. Show less Coordinates and performs the responsibilities related to research application submissions and regulatory document management for Oncology, genetic, and sponsored drug and device studies. Responsible for research compliance, deviation review and CAPA plans. Managed and wrote consent and recruitment documents, protocol review and edits. Responsible for in-house monitoring for multiple sites, source verification and review, GCP and regulatory compliance, Participates in site visits and audits made by sponsors, FDA, or any agency that has regulatory oversight. Responsible for industry, government funded, and investigator initiated trials. Show less

  • Clinical Research Project Coordinator

    Mar 2021 - now

  • Research Regulatory Specialist

    Apr 2017 - Mar 2021