What are the responsibilities and job description for the Compliance and Regulatory Subject Matter Expert (SME) position at University of North Carolina at Chapel Hill?
Posting Information
Department
Med Ad-Deans Office-420104
Career Area
Other
Posting Open Date
02/25/2025
Application Deadline
03/11/2025
Open Until Filled
No
Position Type
Permanent Staff (EHRA NF)
Working Title
Compliance and Regulatory Subject Matter Expert (SME)
Appointment Type
EHRA Non-Faculty
Position Number
20069452
Vacancy ID
NF0008956
Full Time/Part Time
Full-Time Permanent
FTE
1
Hours per week
40
Position Location
North Carolina, US
Hiring Range
Dependent on Qualifications
Proposed Start Date
03/24/2025
Position 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 Compliance and Regulatory Subject Matter Expert (SME) ensures that the School of Medicine (SOM) adheres to the highest standards of compliance and regulatory oversight in research administration. This role provides authoritative guidance on federal, state, and institutional regulations governing clinical and observational research, safeguarding the integrity and ethical standards of SOM’s research activities.
Core responsibilities include interpreting complex regulatory requirements, advising on policy implementation, and conducting compliance reviews. The SME serves as a proactive resource for departments and research administrators, providing insights and training on topics such as human subjects research, data security, conflict of interest, and sponsor-specific requirements.
In collaboration with Pre-/Post-Award SMEs, the Compliance and Regulatory SME develops strategies to mitigate risks and enhance compliance-related processes, aligning them with institutional priorities. Through continuous monitoring, education, and consultation, this role empowers research teams to conduct innovative research while maintaining compliance and regulatory excellence
Core responsibilities include interpreting complex regulatory requirements, advising on policy implementation, and conducting compliance reviews. The SME serves as a proactive resource for departments and research administrators, providing insights and training on topics such as human subjects research, data security, conflict of interest, and sponsor-specific requirements.
In collaboration with Pre-/Post-Award SMEs, the Compliance and Regulatory SME develops strategies to mitigate risks and enhance compliance-related processes, aligning them with institutional priorities. Through continuous monitoring, education, and consultation, this role empowers research teams to conduct innovative research while maintaining compliance and regulatory excellence
Minimum Education and Experience Requirements
Relevant post-Baccalaureate degree required (or foreign degree equivalent); for candidates demonstrating comparable independent research productivity or professional-level background in sponsored research administration, will accept a relevant Bachelor’s degree (or foreign degree equivalent) and 3 or more years of relevant experience in substitution.
Required Qualifications, Competencies, and Experience
Bachelor’s degree in a relevant field (e.g., Business Administration, Research Administration, Public Health, or related area).
Minimum of five years of experience in research administration, with a focus on compliance and regulatory affairs.
Familiarity with a variety of funding sources and mechanisms, including NIH, industry-sponsored clinical trials, and other federal or private grant funding.
Demonstrated ability to provide guidance and training on policies and procedures for developing and administering contracts and grants.
Strong understanding of compliance requirements and the ability to assist in ensuring adherence to federal, state, and institutional regulations.
Excellent analytical and organizational skills, with experience in financial protocol development and policy implementation.
Strong communication and interpersonal skills to effectively collaborate with internal and external stakeholders.
Minimum of five years of experience in research administration, with a focus on compliance and regulatory affairs.
Familiarity with a variety of funding sources and mechanisms, including NIH, industry-sponsored clinical trials, and other federal or private grant funding.
Demonstrated ability to provide guidance and training on policies and procedures for developing and administering contracts and grants.
Strong understanding of compliance requirements and the ability to assist in ensuring adherence to federal, state, and institutional regulations.
Excellent analytical and organizational skills, with experience in financial protocol development and policy implementation.
Strong communication and interpersonal skills to effectively collaborate with internal and external stakeholders.
Preferred Qualifications, Competencies, and Experience
Master’s degree or higher in a related field.
Certification in Research Administration (e.g., CRA, CPRA).
Experience managing complex grants or clinical trial funding.
Certification in Research Administration (e.g., CRA, CPRA).
Experience managing complex grants or clinical trial funding.
Special Physical/Mental Requirements
Ability to work in a fast-paced environment, manage multiple priorities, and meet tight deadlines.
Attention to detail and capacity to focus on complex regulatory and financial compliance issues.
Strong critical thinking and problem-solving skills to address dynamic research administration challenges.
Attention to detail and capacity to focus on complex regulatory and financial compliance issues.
Strong critical thinking and problem-solving skills to address dynamic research administration challenges.
Campus Security Authority Responsibilities
Not Applicable.
