Department | TraCS Institute-429801 |
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Career Area | Research Professionals |
Posting Open Date | 03/06/2024 |
Application Deadline | 03/23/2024 |
Open Until Filled | No |
Position Type | Permanent Staff (EHRA NF) |
Working Title | Director of Regulatory Operations |
Appointment Type | EHRA Non-Faculty |
Position Number | 01000668 |
Vacancy ID | NF0007908 |
Full Time/Part Time | Full-Time Permanent |
FTE | 1 |
Hours per week | 40 |
Position Location | North Carolina, US |
Hiring Range | $95,000 – $170,000 |
Proposed Start Date | 04/15/2024 |
Be a Tar Heel! |
A global higher education leader in innovative teaching, research and public service, the consistently ranks as . 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 for career growth, skill development and lifelong learning and enjoy 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 , paid leave, and a variety of health, life and retirement plans and additional programs that support a healthy work/life balance. |
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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 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. |
Position Summary |
Flexible work arrangements, including virtual/hybrid work locations, are an integral part of the School of Medicine’s Working Forward initiative. As such, this position’s work location is designated as hybrid. Please note that the designated work location is subject to change based on the unit’s business needs. The Director of Regulatory Operations will lead and oversee the application of regulatory guidelines, standards, and policies for a diverse array of projects and initiatives of the North Carolina Translational and Clinical Sciences Institute (NC TraCS), ensuring compliance and best practices. This position will support UNC’s involvement in the All of Us Center for Linkage and Acquisition of Data initiative by leading the Program Compliance Core (PCC). This involves direct engagement with the National Institutes of Health, participating sites, and data brokers. As the All of Us PCC Core lead, this position is responsible for organizing the complex regulatory process of bringing participant data from multiple sources together. The Director will serve as the subject matter expert both internally and externally with TraCS partners and collaborators. The Director will also lead the development, testing, and evaluation of innovative projects aimed at addressing translational science barriers as they relate to research quality and compliance. |
Minimum Education and Experience Requirements |
Relevant post-Baccalaureate degree required (or foreign degree equivalent); for candidates demonstrating comparable independent research productivity, will accept a relevant Bachelor’s degree (or foreign degree equivalent) and 3 or more years of relevant experience in substitution. May require terminal degree and licensure. |
Required Qualifications, Competencies, and Experience |
Required qualifications include: * Knowledge of National Institutes of Health and Institutional Review Board guidelines * Knowledge of HIPAA compliance requirements and standards * Demonstrated capacity to manage and coordinate programs in a complex and dynamic environment and under critical timelines * Ability to think critically and creatively and to work collaboratively across diverse partners and stakeholders * Superior communication skills, both verbal and written |
Preferred Qualifications, Competencies, and Experience |
Preferred qualifications include: * At least 5 years of experience in clinical research with advanced knowledge of clinical research regulations; experience with all study types, including observational, behavioral, clinical trials, and FDA-regulated trials * Knowledge of Clinical and Translational Science Awards programs and operations |
Special Physical/Mental Requirements | |
Campus Security Authority Responsibilities |
Not Applicable. |
Special Instructions |
As the All of Us Program Compliance Core Lead, this position is responsible for organizing the complex regulatory process of bringing participant data from multiple sources together. In their application, candidates are asked to highlight experiences that would support them in this role (e.g., national leadership, experience with big data sharing, data governance). |
Quick Link |
Department Contact Name and Title | Stephanie Fleming, HR Consultant |
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Department Contact Telephone or Email | [email protected] |
Office of Human Resources Contact Information |
If you experience any problems accessing the system or have questions about the application process, please contact the Office of Human Resources at (919) 843-2300 or send an email to |
Equal Opportunity Employer Statement |
The University of North Carolina at Chapel Hill is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or status as a protected veteran. |
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