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    West Virginia University

    Higher Education

    Clinical Research Quality & Regulatory Specialist - Rockefeller Neuroscience Institute

    Morgantown, United StatesOn-SiteFull-timePosted 2d ago
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    Job description

    %3Cp%3E%3Cspan style=%22font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3EThe Rockefeller Neuroscience Institute at West Virginia University is currently accepting applications for a Clinical Research Quality %26amp; Regulatory Specialist.%3C/span%3E%3C/p%3E%3Cp class=%22MsoNormal%22 style=%22line-height%5C:normal;text-align%5C:justify;%22%3E%3Cspan style=%22font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-ascii-theme-font%5C:major-latin;mso-bidi-font-family%5C:%26quot;Aptos Display%26quot;;mso-bidi-theme-font%5C:major-latin;mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-hansi-theme-font%5C:major-latin;%22%3E%3Cstrong%3E%3Cu%3ERockefeller Neuroscience Institute%3C/u%3E%3C/strong%3E%3C/span%3E%3C/span%3E%3C/p%3E%3Cp class=%22MsoNormal%22 style=%22line-height%5C:normal;text-align%5C:justify;%22%3E%3Cspan style=%22font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-ascii-theme-font%5C:major-latin;mso-bidi-font-family%5C:%26quot;Aptos Display%26quot;;mso-bidi-font-weight%5C:bold;mso-bidi-theme-font%5C:major-latin;mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-hansi-theme-font%5C:major-latin;%22%3EThe WVU Rockefeller Neuroscience Institute (RNI) is a comprehensive multidisciplinary patient care, education, and research institute providing neurological and mental healthcare through more than 300,000 visits annually. The 300+ physicians and scientists of the RNI improve lives by pioneering advances in neuroscience, brain health, and therapeutics. The RNI team uses the latest technologies with academic, government, and industry partners to make tangible progress to combat public health challenges ranging from addiction to Alzheimer’s disease.%3C/span%3E%3C/span%3E%3C/p%3E%3Cp class=%22MsoNormal%22 style=%22line-height%5C:normal;margin-bottom%5C:0in;text-align%5C:justify;%22%3E%3Cspan style=%22font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-ascii-theme-font%5C:major-latin;mso-bidi-font-family%5C:%26quot;Aptos Display%26quot;;mso-bidi-font-weight%5C:bold;mso-bidi-theme-font%5C:major-latin;mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-hansi-theme-font%5C:major-latin;%22%3EThe RNI’s flagship facilities are located on the WVU Health Sciences campus in Morgantown, with more than 2,200 dedicated team members across seven departments, patient care units, and research laboratories.%3C/span%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3E For more information, visit%26nbsp;%3C/span%3E%3C/span%3E%3Ca href=%22https%5C://wvumedicine.org/RNI%22 target=%22_blank%22 title=%22https%5C://wvumedicine.org/rni%22%3E%3Cspan style=%22color%5C:blue;font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3EWVUMedicine.org/RNI%3C/span%3E%3C/span%3E%3C/a%3E%3Cspan style=%22font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3E.%3C/span%3E%3C/span%3E%3C/p%3E%3Cp class=%22MsoNormal%22 style=%22line-height%5C:normal;margin-bottom%5C:0in;text-align%5C:justify;%22%3E%3Cspan style=%22font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cstrong%3E%3Cu%3EAbout the Opportunity%3C/u%3E%3C/strong%3E%3C/span%3E%3C/p%3E%3Cp class=%22MsoNormal%22 style=%22line-height%5C:normal;margin-bottom%5C:0in;text-align%5C:justify;%22%3E%3Cspan style=%22font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3EResponsible for regulatory management of all protocols ensuring compliance with IRB policies and applicable regulations. %3C/span%3E%3Cspan style=%22color%5C:black;font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3EWe strongly believe in work-life balance and keeping time for things we love outside our work. WVU offers generous benefits, including%5C:%3C/span%3E%3C/span%3E%3Cbr%3E%26nbsp;%3C/p%3E%3Cul%3E%3Cli%3E%3Cp class=%22MsoNormal%22 style=%22line-height%5C:normal;margin-bottom%5C:0in;text-align%5C:justify;%22%3E%3Cspan style=%22font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3E37.5-hour work week%26nbsp;%3C/span%3E%3C/span%3E%3C/p%3E%3C/li%3E%3Cli class=%22MsoNormal%22 style=%22background-color%5C:white;color%5C:black;line-height%5C:normal;mso-list%5C:l0 level1 lfo1;mso-margin-bottom-alt%5C:auto;mso-margin-top-alt%5C:auto;tab-stops%5C:list .5in;vertical-align%5C:middle;%22%3E%3Cspan style=%22font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3E13 paid holidays%26nbsp;(%3C/span%3E%3C/span%3E%3Ca href=%22https%5C://talentandculture.wvu.edu/benefits-and-compensation/holiday-schedule%22%3E%3Cspan style=%22color%5C:#045FAB;font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3Estaff holiday calendar%3C/span%3E%3C/span%3E%3C/a%3E%3Cspan style=%22font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3E)%3C/span%3E%3C/span%3E%3C/li%3E%3Cli class=%22MsoNormal%22 style=%22background-color%5C:white;color%5C:black;line-height%5C:normal;mso-list%5C:l0 level1 lfo1;mso-margin-bottom-alt%5C:auto;mso-margin-top-alt%5C:auto;tab-stops%5C:list .5in;vertical-align%5C:middle;%22%3E%3Cspan style=%22font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3E24 annual leave (vacation) days per year (%3C/span%3E%3C/span%3E%3Ca href=%22https%5C://talentandculture.wvu.edu/benefits-and-compensation/time-off/ee-leave%22%3E%3Cspan style=%22color%5C:#045FAB;font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3Eemployee leave%3C/span%3E%3C/span%3E%3C/a%3E%3Cspan style=%22font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3E)%3C/span%3E%3C/span%3E%3C/li%3E%3Cli class=%22MsoNormal%22 style=%22background-color%5C:white;color%5C:black;line-height%5C:normal;mso-list%5C:l0 level1 lfo1;mso-margin-bottom-alt%5C:auto;mso-margin-top-alt%5C:auto;tab-stops%5C:list .5in;vertical-align%5C:middle;%22%3E%3Cspan style=%22font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3E18 sick days per year%26nbsp;(for when you’re ill, for when you need time to care for sick family, for your own, or your family’s, regularly scheduled medical appointments. Who is family for the purpose of this leave? A lot of people in your life including immediate relatives and in-laws as well as others considered to be members of your household living under the same roof)%3C/span%3E%3C/span%3E%3C/li%3E%3Cli class=%22MsoNormal%22 style=%22background-color%5C:white;color%5C:black;line-height%5C:normal;mso-list%5C:l0 level1 lfo1;mso-margin-bottom-alt%5C:auto;mso-margin-top-alt%5C:auto;tab-stops%5C:list .5in;vertical-align%5C:middle;%22%3E%3Cspan style=%22font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3EWVU offers a range of%26nbsp;%3C/span%3E%3C/span%3E%3Ca href=%22https%5C://talentandculture.wvu.edu/benefits-and-compensation/insurance-plans%22%3E%3Cspan style=%22color%5C:#045FAB;font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3Ehealth insurance and other benefits%3C/span%3E%3C/span%3E%3C/a%3E%3C/li%3E%3Cli class=%22MsoNormal%22 style=%22background-color%5C:white;color%5C:black;line-height%5C:normal;mso-list%5C:l0 level1 lfo1;mso-margin-bottom-alt%5C:auto;mso-margin-top-alt%5C:auto;tab-stops%5C:list .5in;vertical-align%5C:middle;%22%3E%3Cspan style=%22font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3E401(a) retirement savings with 6% employee contribution match, eligibility to continue health insurance, and other retiree perks. Looking for%26nbsp;%3C/span%3E%3C/span%3E%3Ca href=%22https%5C://talentandculture.wvu.edu/benefits-and-compensation/retirement%22%3E%3Cspan style=%22color%5C:#045FAB;font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3Emore retirement benefits information%3C/span%3E%3C/span%3E%3C/a%3E%3Cspan style=%22font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3E? Check out retirement health insurance benefits, retirement income, and FAQ’s.%3C/span%3E%3C/span%3E%3C/li%3E%3Cli class=%22MsoNormal%22 style=%22background-color%5C:white;color%5C:black;line-height%5C:normal;mso-list%5C:l0 level1 lfo1;mso-margin-bottom-alt%5C:auto;mso-margin-top-alt%5C:auto;tab-stops%5C:list .5in;vertical-align%5C:middle;%22%3E%3Cspan style=%22font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3EWellness programs%3C/span%3E%3C/span%3E%3C/li%3E%3C/ul%3E%3Cp class=%22MsoNormal%22 style=%22background-color%5C:white;line-height%5C:normal;margin-bottom%5C:9.0pt;vertical-align%5C:middle;%22%3E%3Cspan style=%22color%5C:black;font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3E%3Cstrong%3E%3Cu%3EWhat You%27ll Do%3C/u%3E%3C/strong%3E%3C/span%3E%3C/span%3E%3C/p%3E%3Cul%3E%3Cli%3E%3Cspan style=%22color%5C:black;font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Ci%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3E%3Cstrong%3EPlanning and Developing%5C:%3C/strong%3E%3C/span%3E%3C/i%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3E%26nbsp;%3C/span%3E%3C/span%3E%3Cul%3E%3Cli%3E%3Cspan style=%22color%5C:black;font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3EFunction as a project quality manager liaising with the other functional groups (data, imaging, etc.) In collaboration with the Director of operations manages all aspects of clinical research quality control from project proposal, Institutional (IRB) approval, study conduct, data analysis and close out.%26nbsp;%3C/span%3E%3C/span%3E%3C/li%3E%3Cli%3E%3Cspan style=%22color%5C:black;font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3EDevelops research protocols, data management and trial management plans.%3C/span%3E%3C/span%3E%3C/li%3E%3Cli%3E%3Cspan style=%22color%5C:black;font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3EDevelops Standard Operation Procedures for Research personnel%3C/span%3E%3C/span%3E%3C/li%3E%3C/ul%3E%3C/li%3E%3Cli%3E%3Cspan style=%22color%5C:black;font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Ci%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3E%3Cstrong%3EDay to Day Activities%5C:%26nbsp;%3C/strong%3E%3C/span%3E%3C/i%3E%3C/span%3E%3Cul%3E%3Cli%3E%3Cspan style=%22color%5C:black;font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3EPossess a sound and in-depth understanding of each protocol and provides administrative, quality and regulatory management ensuring compliance with IRB, GCP guidelines and code of federal regulations Responsible for regulatory management of all protocols ensuring compliance with IRB policies and applicable regulations%3C/span%3E%3C/span%3E%3C/li%3E%3Cli%3E%3Cspan style=%22color%5C:black;font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3EPrepares protocols and ongoing amendments for initial IRB submission including preparation of IRB Protocol Statement, Abstract, Consent and Assent Forms and Discussion.%3C/span%3E%3C/span%3E%3C/li%3E%3Cli%3E%3Cspan style=%22color%5C:black;font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3EPrepares and maintains submissions to regulatory bodies through the study life time E.g.%5C: IND and IDE preparation, submission and maintenance)-%26nbsp;%3C/span%3E%3C/span%3E%3C/li%3E%3Cli%3E%3Cspan style=%22color%5C:black;font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3EPrepares reports and functions as a liaison between Pl, IRB, sponsor, research team, and participants%3C/span%3E%3C/span%3E%3C/li%3E%3Cli%3E%3Cspan style=%22color%5C:black;font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3EManages multiple projects/protocols concurrently in a dynamic environment.%3C/span%3E%3C/span%3E%3C/li%3E%3Cli%3E%3Cspan style=%22color%5C:black;font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3EPrepares, monitors, validates, and maintains all research documentations%3C/span%3E%3C/span%3E%3C/li%3E%3Cli%3E%3Cspan style=%22color%5C:black;font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3EScreens, enroll, and schedules research subjects to ensure compliance to research protocols%3C/span%3E%3C/span%3E%3C/li%3E%3Cli%3E%3Cspan style=%22color%5C:black;font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3EAssist with all aspects of data and source documentation, adverse experience reporting and maintenance of complete regulatory files.%3C/span%3E%3C/span%3E%3C/li%3E%3Cli%3E%3Cspan style=%22color%5C:black;font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3EAssist in the implementation, system administration and maintenance of patient databases including but not limited to the collection, analysis, and reporting of patient outcomes data.%3C/span%3E%3C/span%3E%3C/li%3E%3Cli%3E%3Cspan style=%22color%5C:black;font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3EPerforms education training related to RNI research activities. Assist in support, training and onboarding of new research staff. Participates in writing of reports and other documentation of project status and project results Arranges and attends meetings, seminars, symposia and other events related to project efforts Work regularly with EPIC systems analysts and third party software developers to maintain the vendor interface, and to communicate and resolve issues.%3C/span%3E%3C/span%3E%3C/li%3E%3C/ul%3E%3C/li%3E%3C/ul%3E %3Cp%3E%3Cspan style=%22font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3EThe Rockefeller Neuroscience Institute at West Virginia University is currently accepting applications for a Clinical Research Quality %26amp; Regulatory Specialist.%3C/span%3E%3C/p%3E%3Cp class=%22MsoNormal%22 style=%22line-height%5C:normal;text-align%5C:justify;%22%3E%3Cspan style=%22font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-ascii-theme-font%5C:major-latin;mso-bidi-font-family%5C:%26quot;Aptos Display%26quot;;mso-bidi-theme-font%5C:major-latin;mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-hansi-theme-font%5C:major-latin;%22%3E%3Cstrong%3E%3Cu%3ERockefeller Neuroscience Institute%3C/u%3E%3C/strong%3E%3C/span%3E%3C/span%3E%3C/p%3E%3Cp class=%22MsoNormal%22 style=%22line-height%5C:normal;text-align%5C:justify;%22%3E%3Cspan style=%22font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-ascii-theme-font%5C:major-latin;mso-bidi-font-family%5C:%26quot;Aptos Display%26quot;;mso-bidi-font-weight%5C:bold;mso-bidi-theme-font%5C:major-latin;mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-hansi-theme-font%5C:major-latin;%22%3EThe WVU Rockefeller Neuroscience Institute (RNI) is a comprehensive multidisciplinary patient care, education, and research institute providing neurological and mental healthcare through more than 300,000 visits annually. The 300+ physicians and scientists of the RNI improve lives by pioneering advances in neuroscience, brain health, and therapeutics. The RNI team uses the latest technologies with academic, government, and industry partners to make tangible progress to combat public health challenges ranging from addiction to Alzheimer’s disease.%3C/span%3E%3C/span%3E%3C/p%3E%3Cp class=%22MsoNormal%22 style=%22line-height%5C:normal;margin-bottom%5C:0in;text-align%5C:justify;%22%3E%3Cspan style=%22font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-ascii-theme-font%5C:major-latin;mso-bidi-font-family%5C:%26quot;Aptos Display%26quot;;mso-bidi-font-weight%5C:bold;mso-bidi-theme-font%5C:major-latin;mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-hansi-theme-font%5C:major-latin;%22%3EThe RNI’s flagship facilities are located on the WVU Health Sciences campus in Morgantown, with more than 2,200 dedicated team members across seven departments, patient care units, and research laboratories.%3C/span%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3E For more information, visit%26nbsp;%3C/span%3E%3C/span%3E%3Ca href=%22https%5C://wvumedicine.org/RNI%22 target=%22_blank%22 title=%22https%5C://wvumedicine.org/rni%22%3E%3Cspan style=%22color%5C:blue;font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3EWVUMedicine.org/RNI%3C/span%3E%3C/span%3E%3C/a%3E%3Cspan style=%22font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3E.%3C/span%3E%3C/span%3E%3C/p%3E%3Cp class=%22MsoNormal%22 style=%22line-height%5C:normal;margin-bottom%5C:0in;text-align%5C:justify;%22%3E%3Cspan style=%22font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cstrong%3E%3Cu%3EAbout the Opportunity%3C/u%3E%3C/strong%3E%3C/span%3E%3C/p%3E%3Cp class=%22MsoNormal%22 style=%22line-height%5C:normal;margin-bottom%5C:0in;text-align%5C:justify;%22%3E%3Cspan style=%22font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3EResponsible for regulatory management of all protocols ensuring compliance with IRB policies and applicable regulations. %3C/span%3E%3Cspan style=%22color%5C:black;font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3EWe strongly believe in work-life balance and keeping time for things we love outside our work. WVU offers generous benefits, including%5C:%3C/span%3E%3C/span%3E%3Cbr%3E%26nbsp;%3C/p%3E%3Cul%3E%3Cli%3E%3Cp class=%22MsoNormal%22 style=%22line-height%5C:normal;margin-bottom%5C:0in;text-align%5C:justify;%22%3E%3Cspan style=%22font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3E37.5-hour work week%26nbsp;%3C/span%3E%3C/span%3E%3C/p%3E%3C/li%3E%3Cli class=%22MsoNormal%22 style=%22background-color%5C:white;color%5C:black;line-height%5C:normal;mso-list%5C:l0 level1 lfo1;mso-margin-bottom-alt%5C:auto;mso-margin-top-alt%5C:auto;tab-stops%5C:list .5in;vertical-align%5C:middle;%22%3E%3Cspan style=%22font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3E13 paid holidays%26nbsp;(%3C/span%3E%3C/span%3E%3Ca href=%22https%5C://talentandculture.wvu.edu/benefits-and-compensation/holiday-schedule%22%3E%3Cspan style=%22color%5C:#045FAB;font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3Estaff holiday calendar%3C/span%3E%3C/span%3E%3C/a%3E%3Cspan style=%22font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3E)%3C/span%3E%3C/span%3E%3C/li%3E%3Cli class=%22MsoNormal%22 style=%22background-color%5C:white;color%5C:black;line-height%5C:normal;mso-list%5C:l0 level1 lfo1;mso-margin-bottom-alt%5C:auto;mso-margin-top-alt%5C:auto;tab-stops%5C:list .5in;vertical-align%5C:middle;%22%3E%3Cspan style=%22font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3E24 annual leave (vacation) days per year (%3C/span%3E%3C/span%3E%3Ca href=%22https%5C://talentandculture.wvu.edu/benefits-and-compensation/time-off/ee-leave%22%3E%3Cspan style=%22color%5C:#045FAB;font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3Eemployee leave%3C/span%3E%3C/span%3E%3C/a%3E%3Cspan style=%22font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3E)%3C/span%3E%3C/span%3E%3C/li%3E%3Cli class=%22MsoNormal%22 style=%22background-color%5C:white;color%5C:black;line-height%5C:normal;mso-list%5C:l0 level1 lfo1;mso-margin-bottom-alt%5C:auto;mso-margin-top-alt%5C:auto;tab-stops%5C:list .5in;vertical-align%5C:middle;%22%3E%3Cspan style=%22font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3E18 sick days per year%26nbsp;(for when you’re ill, for when you need time to care for sick family, for your own, or your family’s, regularly scheduled medical appointments. Who is family for the purpose of this leave? A lot of people in your life including immediate relatives and in-laws as well as others considered to be members of your household living under the same roof)%3C/span%3E%3C/span%3E%3C/li%3E%3Cli class=%22MsoNormal%22 style=%22background-color%5C:white;color%5C:black;line-height%5C:normal;mso-list%5C:l0 level1 lfo1;mso-margin-bottom-alt%5C:auto;mso-margin-top-alt%5C:auto;tab-stops%5C:list .5in;vertical-align%5C:middle;%22%3E%3Cspan style=%22font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3EWVU offers a range of%26nbsp;%3C/span%3E%3C/span%3E%3Ca href=%22https%5C://talentandculture.wvu.edu/benefits-and-compensation/insurance-plans%22%3E%3Cspan style=%22color%5C:#045FAB;font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3Ehealth insurance and other benefits%3C/span%3E%3C/span%3E%3C/a%3E%3C/li%3E%3Cli class=%22MsoNormal%22 style=%22background-color%5C:white;color%5C:black;line-height%5C:normal;mso-list%5C:l0 level1 lfo1;mso-margin-bottom-alt%5C:auto;mso-margin-top-alt%5C:auto;tab-stops%5C:list .5in;vertical-align%5C:middle;%22%3E%3Cspan style=%22font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3E401(a) retirement savings with 6% employee contribution match, eligibility to continue health insurance, and other retiree perks. Looking for%26nbsp;%3C/span%3E%3C/span%3E%3Ca href=%22https%5C://talentandculture.wvu.edu/benefits-and-compensation/retirement%22%3E%3Cspan style=%22color%5C:#045FAB;font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3Emore retirement benefits information%3C/span%3E%3C/span%3E%3C/a%3E%3Cspan style=%22font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3E? Check out retirement health insurance benefits, retirement income, and FAQ’s.%3C/span%3E%3C/span%3E%3C/li%3E%3Cli class=%22MsoNormal%22 style=%22background-color%5C:white;color%5C:black;line-height%5C:normal;mso-list%5C:l0 level1 lfo1;mso-margin-bottom-alt%5C:auto;mso-margin-top-alt%5C:auto;tab-stops%5C:list .5in;vertical-align%5C:middle;%22%3E%3Cspan style=%22font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3EWellness programs%3C/span%3E%3C/span%3E%3C/li%3E%3C/ul%3E%3Cp class=%22MsoNormal%22 style=%22background-color%5C:white;line-height%5C:normal;margin-bottom%5C:9.0pt;vertical-align%5C:middle;%22%3E%3Cspan style=%22color%5C:black;font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3E%3Cstrong%3E%3Cu%3EWhat You%27ll Do%3C/u%3E%3C/strong%3E%3C/span%3E%3C/span%3E%3C/p%3E%3Cul%3E%3Cli%3E%3Cspan style=%22color%5C:black;font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Ci%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3E%3Cstrong%3EPlanning and Developing%5C:%3C/strong%3E%3C/span%3E%3C/i%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3E%26nbsp;%3C/span%3E%3C/span%3E%3Cul%3E%3Cli%3E%3Cspan style=%22color%5C:black;font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3EFunction as a project quality manager liaising with the other functional groups (data, imaging, etc.) In collaboration with the Director of operations manages all aspects of clinical research quality control from project proposal, Institutional (IRB) approval, study conduct, data analysis and close out.%26nbsp;%3C/span%3E%3C/span%3E%3C/li%3E%3Cli%3E%3Cspan style=%22color%5C:black;font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3EDevelops research protocols, data management and trial management plans.%3C/span%3E%3C/span%3E%3C/li%3E%3Cli%3E%3Cspan style=%22color%5C:black;font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3EDevelops Standard Operation Procedures for Research personnel%3C/span%3E%3C/span%3E%3C/li%3E%3C/ul%3E%3C/li%3E%3Cli%3E%3Cspan style=%22color%5C:black;font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Ci%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3E%3Cstrong%3EDay to Day Activities%5C:%26nbsp;%3C/strong%3E%3C/span%3E%3C/i%3E%3C/span%3E%3Cul%3E%3Cli%3E%3Cspan style=%22color%5C:black;font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3EPossess a sound and in-depth understanding of each protocol and provides administrative, quality and regulatory management ensuring compliance with IRB, GCP guidelines and code of federal regulations Responsible for regulatory management of all protocols ensuring compliance with IRB policies and applicable regulations%3C/span%3E%3C/span%3E%3C/li%3E%3Cli%3E%3Cspan style=%22color%5C:black;font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3EPrepares protocols and ongoing amendments for initial IRB submission including preparation of IRB Protocol Statement, Abstract, Consent and Assent Forms and Discussion.%3C/span%3E%3C/span%3E%3C/li%3E%3Cli%3E%3Cspan style=%22color%5C:black;font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3EPrepares and maintains submissions to regulatory bodies through the study life time E.g.%5C: IND and IDE preparation, submission and maintenance)-%26nbsp;%3C/span%3E%3C/span%3E%3C/li%3E%3Cli%3E%3Cspan style=%22color%5C:black;font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3EPrepares reports and functions as a liaison between Pl, IRB, sponsor, research team, and participants%3C/span%3E%3C/span%3E%3C/li%3E%3Cli%3E%3Cspan style=%22color%5C:black;font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3EManages multiple projects/protocols concurrently in a dynamic environment.%3C/span%3E%3C/span%3E%3C/li%3E%3Cli%3E%3Cspan style=%22color%5C:black;font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3EPrepares, monitors, validates, and maintains all research documentations%3C/span%3E%3C/span%3E%3C/li%3E%3Cli%3E%3Cspan style=%22color%5C:black;font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3EScreens, enroll, and schedules research subjects to ensure compliance to research protocols%3C/span%3E%3C/span%3E%3C/li%3E%3Cli%3E%3Cspan style=%22color%5C:black;font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3EAssist with all aspects of data and source documentation, adverse experience reporting and maintenance of complete regulatory files.%3C/span%3E%3C/span%3E%3C/li%3E%3Cli%3E%3Cspan style=%22color%5C:black;font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3EAssist in the implementation, system administration and maintenance of patient databases including but not limited to the collection, analysis, and reporting of patient outcomes data.%3C/span%3E%3C/span%3E%3C/li%3E%3Cli%3E%3Cspan style=%22color%5C:black;font-family%5C:Arial, Helvetica, sans-serif;font-size%5C:14px;%22%3E%3Cspan style=%22mso-fareast-font-family%5C:%26quot;Times New Roman%26quot;;mso-font-kerning%5C:0pt;mso-ligatures%5C:none;%22%3EPerforms education training related to RNI research activities. Assist in support, training and onboarding of new research staff. Participates in writing of reports and other documentation of project status and project results Arranges and attends meetings, seminars, symposia and other events related to project efforts Work regularly with EPIC systems analysts and third party software developers to maintain the vendor interface, and to communicate and resolve issues.%3C/span%3E%3C/span%3E%3C/li%3E%3C/ul%3E%3C/li%3E%3C/ul%3E
    • Bachelor's degree in a health related field
    • A minimum of two (2) years of combined experience in the following:
      • Program Coordination
      • Clinical experience
    • Any equivalent combination of related education and/or experience will be considered.
    • All qualifications must be met by the time of employment.

    Knowledge, Skills, and Abilities

    • Maintains skills in, or knowledge of, internal funding mechanisms such as pilot grants
    • Excellent English language oral and written skills 
    • Strong organizational skills 
    • Demonstrated ability to read and interpret documents 
    • Demonstrated ability to present information and respond to questions from groups or individuals 
    • Demonstrated ability to create and produce clear, concise paper and electronic documents 
    • Demonstrated ability to work in a multidisciplinary team environment and to coordinate participation of team members from various backgrounds 
    • Demonstrated project management experience preferred with exceptional organizational and time management skills 
    • Group facilitation, mediation and conflict resolution skills 
    • Skill in organizing resources and establishing priorities.

    Preferred Qualifications

    • A minimum of five (5) years of clinical experience preferred.
    • Bachelor's degree in a health related field
    • A minimum of two (2) years of combined experience in the following:
      • Program Coordination
      • Clinical experience
    • Any equivalent combination of related education and/or experience will be considered.
    • All qualifications must be met by the time of employment.

    Knowledge, Skills, and Abilities

    • Maintains skills in, or knowledge of, internal funding mechanisms such as pilot grants
    • Excellent English language oral and written skills 
    • Strong organizational skills 
    • Demonstrated ability to read and interpret documents 
    • Demonstrated ability to present information and respond to questions from groups or individuals 
    • Demonstrated ability to create and produce clear, concise paper and electronic documents 
    • Demonstrated ability to work in a multidisciplinary team environment and to coordinate participation of team members from various backgrounds 
    • Demonstrated project management experience preferred with exceptional organizational and time management skills 
    • Group facilitation, mediation and conflict resolution skills 
    • Skill in organizing resources and establishing priorities.

    Preferred Qualifications

    • A minimum of five (5) years of clinical experience preferred.

    Obtain certification as a Research Professional through the Society of Clinical Research Associates (SoCRA) OR the Association of Clinical Research Professionals (ACRP) with three years of hire date. 

    Obtain certification as a Research Professional through the Society of Clinical Research Associates (SoCRA) OR the Association of Clinical Research Professionals (ACRP) with three years of hire date. 

    West Virginia University is a place of purpose and community. We take pride in our profound impact on the state of West Virginia and are committed to the personal and professional growth of our employees.

    From the groundbreaking R1 research at our flagship campus in Morgantown to the career-oriented programs at WVU Potomac State in Keyser, and the technology-intensive programs at WVU Tech in Beckley, the contributions of WVU employees resonate across the state, touching lives and shaping futures.

    At WVU, you will discover a supportive community that champions work-life balance and fosters a collaborative atmosphere. Our core values — service, curiosity, respect, accountability and appreciation — unite us as Mountaineers.

    Join us at West Virginia University, where your work will make a lasting impact. To learn more about WVU, visit wvu.edu.

    West Virginia University is an Equal Opportunity Employer. We invite all qualified applicants regardless of race, color, religion, sex, national origin, age, disability, genetic information, or Veteran status.  

    West Virginia University is a place of purpose and community. We take pride in our profound impact on the state of West Virginia and are committed to the personal and professional growth of our employees.

    From the groundbreaking R1 research at our flagship campus in Morgantown to the career-oriented programs at WVU Potomac State in Keyser, and the technology-intensive programs at WVU Tech in Beckley, the contributions of WVU employees resonate across the state, touching lives and shaping futures.

    At WVU, you will discover a supportive community that champions work-life balance and fosters a collaborative atmosphere. Our core values — service, curiosity, respect, accountability and appreciation — unite us as Mountaineers.

    Join us at West Virginia University, where your work will make a lasting impact. To learn more about WVU, visit wvu.edu.

    West Virginia University is an Equal Opportunity Employer. We invite all qualified applicants regardless of race, color, religion, sex, national origin, age, disability, genetic information, or Veteran status.  

    Job details are sourced from the employer's original posting.

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    WE

    About the company

    West Virginia University

    A public research university providing undergraduate and graduate education across multiple disciplines.

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