Kirsten Bugden

Kirsten bugden

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location of Kirsten BugdenCharlottesville, Virginia, United States
Phone number of Kirsten Bugden+91 xxxx xxxxx
Followers of Kirsten Bugden160 followers
  • Timeline

    Oct 2011 - Aug 2012

    Wildlife Intern

    Animal Welfare Institute
    Aug 2012 - Jul 2014

    Graduate Assistant for the Research Compliance Office

    Radford University
    Current Company
    Dec 2014 - now

    Regulatory Compliance Manager

    University of Virginia
    Charlottesville, Virginia, United States
  • About me

    Regulatory Compliance Manager, Cancer Center Office of Clinical Research at University of Virginia

  • Education

    • Augustana college

      2007 - 2011
      Bachelor of arts psychology and biology

      Activities and Societies: Alpha Phi Omega, Habitat for Humanity, Sigma Xi Studied abroad in Japan, China, Hong Kong, and Taiwan for the Fall 2010 Trimester. Volunteered in Texas (February 2009) and South Carolina (February 2011) for Habitat for Humanity, along with the houses in Rock Island, IL year-round (2009-2011). Participated as Fundraiser Co-Chair for Augustana College's Habitat for Humanity Chapter (2009-2011).

    • Radford university

      2012 - 2014
      Master of arts (m.a.) experimental psychology gpa 3.81

      Activities and Societies: Society for Integrative and Comparative Biology

  • Experience

    • Animal welfare institute

      Oct 2011 - Aug 2012
      Wildlife intern

      • Assisted wildlife biologist, D.J. Schubert in preservation of wild horses.• Collected literature, contacted Bureau of Land Management officials, input and organized data into Excel spreadsheets. • Participated in various projects and attended governmental meetings related to animal welfare.

    • Radford university

      Aug 2012 - Jul 2014
      Graduate assistant for the research compliance office

      • Extensive review and proofreading of IRB research protocols.• Provides customer service to faculty and students with regards to the IRB submission process, regulations, and electronic submission and website use. • Manages Excel and Access databases, along with other electronic and file record-keeping.• Assists in developing online research compliance training modules • Assists in maintaining IRB website• Trained second graduate assistant in the regulations, processes, procedures, and maintenance of Research Compliance Office. Show less

    • University of virginia

      Dec 2014 - now

      • Submit regulatory documents to Protocol Review Committee and IRB for investigator-initiated, industry, and CIRB studies.• Collaborate with physicians and oncology disease teams to discuss clinical trial needs. • Assist in FDA IND initial reports, annual reports, and modifications submissions.• Edit investigator-initiated protocols during protocol development and post IRB/FDA approval.• Coordinate study activation tasks with sponsors including pre-study visits and confidential disclosure agreements.• Developed UVA Cancer Center Clinical Trials Site Profile and vastly edited the UVA Cancer Center Clinical Research Handbook and Independent Image Analysis Guidelines.• Manage UVA’s NCI rosters for physicians and staff. • Maintain physician membership and register new physicians with the NCI. • Address NCI inquiries related to NCI membership and website access for UVA staff. Show less

      • Regulatory Compliance Manager

        Aug 2021 - now
      • Study Activation Manager, Cancer Center Office of Clinical Research

        Apr 2019 - Aug 2021
      • Regulatory Coordinator, Cancer Center Office of Clinical Research

        Dec 2014 - Apr 2019
  • Licenses & Certifications

    • Certified clinical research professional (ccrp)

      Society of clinical research associates (socra)
      Aug 2019