What are the responsibilities and job description for the Regulatory Documents Specialist position at University of North Carolina at Chapel Hill?
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
02/29/2024
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.
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
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