Director of Regulatory Operations

Research Professionals

03/06/2024

03/19/2024

No

Permanent Staff (EHRA NF)

Director of Regulatory Operations

EHRA Non-Faculty

01000668

NF0007908

Full-Time Permanent

1

40

North Carolina, US

$95,000 - $150,000

04/15/2024

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.

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.

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.

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 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 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

Not Applicable.

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).