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Regulatory Documents Specialist

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Posted : Wednesday, September 06, 2023 08:57 PM

Posting Information Department Globl Hlth and Infect Disease-427801 Career Area Research Professionals Is this an internal only recruitment? No Posting Open Date 02/06/2024 Application Deadline 02/12/2024 Position Type Permanent Staff (SHRA) Position Title Soc/Clin Research Assistant - Journey Salary Grade Equivalent GN08 Working Title Regulatory Documents Specialist Position Number 00055771 Vacancy ID P018655 Full-time/Part-time Permanent/Time-Limited Full-Time Permanent If time-limited, estimated duration of appointment Hours per week 40 Work Schedule Monday – Friday, 8:00am – 5:00pm Work Location Chapel Hill, NC Position Location North Carolina, US Hiring Range $40,944 - $53,341 Pay Band Information To learn more about the pay band for this branch and role, please see the Career Banding rates spreadsheet.
Position Summary Information Be a Tar Heel! 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 The Regulatory Documents Specialist will work within the regulatory department of the Institute for Global Health and Infectious Diseases on clinical research and epidemiological studies.
The primary purpose of this position will be to maintain and organize regulatory documents, study files and training records, communicate with study staff, IRB, sponsors, study partners, arrange meetings between all parties and take minutes, arrange monitoring visits and assist monitors, assist and create submissions for IRB, perform quality control and quality assurance of consent forms, assist in the creation of SOPs and work instructions, create reports of study information, perform other administrative tasks as assigned by supervisor.
Minimum Education and Experience Requirements Bachelor’s degree; or equivalent combination of training and experience.
All degrees must be received from appropriately accredited institutions.
Required Qualifications, Competencies, and Experience Applicants should be knowledgeable about clinical research, IRBs, and regulatory affairs.
Proficiency with Microsoft Word, Excel, PowerPoint, and Outlook.
Preferred Qualifications, Competencies, and Experience Able to work in a fast-paced environment and to alternate between studies and various tasks as needed.
Detail-oriented and conscientious.
Be comfortable communicating with study staff, investigators, IRB, study sponsors, domestic and international study partners, audit staff, including FDA.
Required Licenses/Certifications Special Physical/Mental Requirements Campus Security Authority Responsibilities Not Applicable.
Position/Schedule Requirements

• Phone : NA

• Location : Chapel Hill, NC

• Post ID: 9076102595


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