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Chapel Hill

    Senior Clinical Research Regulatory Coordinator - Chapel Hill, United States - University of North Carolina at Chapel Hill

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    Description

    A global higher education leader in innovative teaching, research and public service, the University of North Carolina at Chapel Hill consistently ranks as one of the nation's top public universities.

    Known for its beautiful campus, world-class medical care, commitment to the arts and top athletic programs, Carolina is an ideal place to teach, work and learn.


    One of the best college towns and best places to live in the United States, Chapel Hill has diverse social, cultural, recreation and professional opportunities that span the campus and community.


    University employees can choose from a wide range of professional training opportunities for career growth, skill development and lifelong learning and enjoy exclusive perks for numerous retail, restaurant and performing arts discounts, savings on local child care centers and special rates on select campus events.

    UNC-Chapel Hill offers full-time employees a comprehensive benefits package, paid leave, and a variety of health, life and retirement plans and additional programs that support a healthy work/life balance.

    Primary Purpose of Organizational Unit

    The UNC School of Medicine has a rich tradition of excellence and care. Our mission is to improve the health and wellbeing of North Carolinians, and others whom we serve. We accomplish this by providing leadership and excellence in the interrelated areas of patient care, education, and research.

    We strive to promote faculty, staff, and learner development in a diverse, respectful environment where our colleagues demonstrate professionalism, enhance learning, and create personal and professional sustainability.

    We optimize our partnership with the UNC Health System through close collaboration and commitment to service.


    OUR VISION
    Our vision is to be the nation's leading public school of medicine.

    We are ranked 2nd in primary care education among all US schools of medicine and 5th among public peers in NIH research funding.

    Our Allied Health Department is home to five top-ranked divisions, and we are home to 18 top-ranked clinical and basic science departments in NIH research funding.


    OUR MISSION
    Our mission is to improve the health and well-being of North Carolinians and others whom we serve. We accomplish this by providing leadership and excellence in the interrelated areas of patient care, education, and research.

    Patient Care:

    We will promote health and provide superb clinical care while maintaining our strong tradition of reaching underserved populations and reducing health disparities across North Carolina and beyond.


    Education:

    We will prepare tomorrow's health care professionals and biomedical researchers by facilitating learning within innovative curricula and team-oriented interprofessional education.

    We will cultivate outstanding teaching and research faculty, and we will recruit outstanding students and trainees from highly diverse backgrounds to create a socially responsible, highly skilled workforce.


    Research:
    We will develop and support a rich array of outstanding health sciences research programs, centers, and resources. We will provide infrastructure and opportunities for collaboration among disciplines throughout and beyond our University to support outstanding research. We will foster programs in the areas of basic, translational, mechanistic, and population research.

    Position Summary


    This position will serve as a Senior Clinical Research Regulatory Coordinator within the Department of Surgery in the Division of Vascular Surgery.

    The Senior Clinical Research Regulatory Coordinator is responsible for regulatory management for multiple and/or concurrent or complex studies, including meeting regulatory-based objectives and deadlines (e.g., IRB submission approvals, IND/IDE submissions, regulatory binder creation, etc.).

    The Senior Clinical Research Regulatory Coordinator will use a full knowledge of clinical research regulatory principles to complete various tasks, such as leading root cause analysis processes, creating of corrective and preventative action plans, regulatory study start-up, and promoting regulatory quality assurance and best practices.

    Minimum Education and Experience Requirements


    Bachelor's degree in a discipline related to the field assigned and one year of related training or experience; or equivalent combination of training and experience.

    All degrees must be received from appropriately accredited institutions.

    Required Qualifications, Competencies, and Experience

    Must be able to use considerable judgement and skills in performing work assignments. Strong written and verbal communication skills. Must be able to work and communicate with diverse populations effectively and professionally. Ability to work independently as well as function as part of a team. Proficient with Microsoft Outlook, Excel, and Word.

    Preferred Qualifications, Competencies, and Experience

    Not applicable

    Special Physical/Mental Requirements Campus Security Authority Responsibilities

    Not Applicable.

    Special Instructions Quick Link


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