Experience

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  Capital Region Medical Center

  • Jefferson City, Missouri, United States

  • Family Medicine Resident

    • Jul 2023 - Present
    • Jefferson City, Missouri, United States

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  Big Tree Medical Home

  • Columbia, Missouri Area

  • Assistant Physican

    • Feb 2018 - Dec 2022
    • Columbia, Missouri Area

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  AbbVie

  • Greater Chicago Area

  • Clinical Study Specialist

    • Jun 2017 - Jan 2018
    • Greater Chicago Area

    • Manage the revisions of Standard Operating Procedures, templates, forms and work instructions according to the established business standards and regulatory requirements to support clinical trials • Create tools to aid teams in understanding processes and procedures (ScreenSteps, QUEST, etc.)• Manage and facilitate the quality document creation/revisions within the quality document system• Conduct Investigational Product release to support trials

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  BioPharma Services Inc.

  • Canada
  • Pharmaceutical Manufacturing
  • 200 - 300 Employee

  • Case Report Form Manager

    • Dec 2016 - Jun 2017

    Supervise a select group of employees charged with documenting all pertinent information required by the FDA on time sensitive and heavily regulated government documents• Capture all variables within a case report form (CRF) with Microsoft Excel and MedDRA to follow FDA guidelines o Use program coding to exclude outliers, append data, designate ranges, identify compliance deviations, and apply conditional formatting for efficient data consumption• Train groups of employees via presentations and mock source documents on HIPPA regulations dealing with sensitive subject identification and medical history• Schedule employee work hours to ensure time sensitive federal documents are delivered within FDA deadlines• Perform quality control and quality assurance audits of case report forms• Interact seamlessly and effectively with FDA and government entities to provide accurate and measurable results

  • Clinical Research Coordinator

    • May 2016 - Jun 2017

    Coordinate, monitor and track the progress and execution of multi-million dollar pharmaceutical studies to ensure that client timelines are met and studies are in compliance with protocol, ICF, SOPs, GCP guidelines and applicable regulations via scrupulous data compilation, QA processes, and communication of trends. • Coordinated pharmaceutical research studies for: FDA, Mylan Pharmaceuticals Inc., Banner Life Sciences, Apotex, West-Ward Pharmaceutical Corp., NATCO, Amneal Pharmaceuticals, Cipla India Ltd., Roxane Laboratories Inc. and Lupin Somerset• Analyze and communicate trends of study’s various adverse effects, dependent upon demographic, gender, ethnicity, etc. • Create time deviation reports by isolating and identifying outliers of study’s data in Excel• Perform investigation reports to discover the cause and propose solutions for major and critical findings that may occur during a study• Generate frameworks for each study, including a protocol and Standard Operating Procedure deviation report, which highlight areas of improvement for future studies• Lead and manage clinic staff (7 nurses, 15 clinical assistants and 25 clinical research technicians) through task delegation, crisis management and clinic logistics• Generate frameworks for each study, including a protocol and Standard Operating Procedure deviation report, which ensure each process follows best practices • Edit study design, protocol preparation and Institutional Review Board (IRB) regulatory requirement proposals for pharmaceutical studies to align deliverable with client expectations • Act as primary analyst for Quality Assurance reports, which are required by the FDA and drug sponsors for the completion of clinical studies • Supervise and lead all aspects of the study, including the initiation, conduct and close-out of multiple FDA and pilot pharmaceutical trials