Experience

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  Worldwide Clinical Trials

  • Senior In-House Clinical Research Associate

    • Aug 2022 - Present

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  Syneos Health

  • Clinical Project Specialist

    • Sep 2021 - Aug 2022

    Provides trial support to clinical projects thereby contributing to the cost efficiency and overall management of clinical trials in accordance with the standards of ICH-GCP and applicable local regulations and Standard Operating Procedures (SOPs)

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  General Dynamics

  • Clinical Research Coordinator

    • Jul 2018 - Sep 2021

    • Manages multiple Department of Defense investigator-initiated studies• Identifies issues and provides appropriate corrective action plans• Establishes excellent working relationships with cross-functional departments to support project goals• Ensures compliance with Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines• Serves as a primary contact for recruitment of patients for various therapeutic studies• Lead in enrollment and randomization of patients per protocol design• Prepares reports and other correspondence regarding the research protocol for the IRB, granting agencies, industry sponsors and other organizations as required by regulation and/or the protocol• Provides an open line of communication with the investigators and study team members to ensure the quality of the research studies are held to the highest standard• Trains new Research personnel • Develops Informed Consent Forms and creates data collection tools• Evaluates and documents the status and progress of each research study subject• Captures all protocol status and IRB documents in an Electronic Institutional Review Board (eIRB) system

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  Eastern Virginia Medical School

  • Norfolk, Virginia, United States

  • Clinical Research Coordinator

    • Nov 2016 - May 2018
    • Norfolk, Virginia, United States

    • Managed multiple investigator- initiated protocols• Recruited and enrolled research patients based on inclusion and exclusion criteria• Reviewed medical records and transcribed data in study specific Electronic Data Capture (EDC) Software such as REDCap (Research Electronic Data Capture) • Conducted internal study audits for research studies• Accountable for procuring, storing, dispensing, and retrieving test articles and maintains temperature logs• Collected biological samples, prepared, shipped, and maintain patient log book• Maintains Regulatory binder and detailed documentation of the research study updates • Conducted monthly meetings with investigators and residents to discuss various research projects

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  NAVAL MEDICAL CENTER PORTSMOUTH

  • Portsmouth, Virginia, United States

  • Credentialing Coordinator

    • Jan 2015 - Nov 2016
    • Portsmouth, Virginia, United States

    • Analyzed, designed, and implemented health care providers (Physicians, Physician Assistants and Nurse Practitioners) Credential Review/Privileging program according to Department of Defense (DOD), NMCP, Bureau of Medicine and Surgery (BUMED) and Joint Commission of Health Organizations (JACHO) policies and directives• Verified provider’s medical education and specialized trainings prior to working in their respective departments• Triaged all medical and educational verification issues and developed a plan of action

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  Westat - Improving Lives Through Research

  • Honolulu, Hawaii, United States

  • Assessment Administrator

    • Jan 2013 - Mar 2013
    • Honolulu, Hawaii, United States

    • Provided survey administration and analysis for national Assessment Education Progress (NEAP)• Organized and prepared assessment materials secured test locations and provided assessments to 4th and 5th graders at multiple schools on island of Oahu• Administered technical instruction regarding assessments in clear, easily understood manner to diverse range of students, checking for clarity and answering all questions as needed • Proctored assessments, insuring test methodology, time limits and completion of test under rigid time constraints• Collected, organized, and provided quality assurance of completed assessments

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  The Research Corporation of the University of Hawai'i

  • Honolulu, Hawaii, United States

  • Clinical Research Associate

    • Nov 2011 - Mar 2012
    • Honolulu, Hawaii, United States

    • Performed quality assurance on all assigned research projects, interpreting and applying complex data and ensuring adherence to all IRB parameters• Analyzed internal administrative procedures to identify inefficiencies, developed solutions, and implement streamlined processes• Prepared clinical research study applications and patient consent forms. • Administered formal correspondence and revised consent forms and applications forms in response to IRB stipulations• Tracked status of sponsor-issued protocol changes, ensured research milestones, and submitted serious Adverse Event (SAE) reports to IRB• Prepared and submitted IRB approvals to national sponsors for site patient enrollment. Maintained protocol regulatory files of all IRB submissions and approvals

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  Westat - Improving Lives Through Research

  • Rockville, Maryland, United States

  • Clinical Research Associate

    • Aug 2008 - May 2011
    • Rockville, Maryland, United States

    • Assisted with development of site monitoring plans, conduct site initiation visits, interim visits, and close-out visits of multiple therapeutic areas assessing compliance with the research protocol, ICH/GCP, FDA, and other applicable regulations, and write detailed reports of findings• Support site compliance with Good Clinical Practice (GCP) including site training, performance improvement recommendations, and corrective and preventive action plans (CAPA)• Contribute to site training, risk assessment, and quality assurance practices