Director-Regulatory Operations

Lineberger Compr Cancer Center-426801

Research Professionals

06/12/2024

06/26/2024

No

Permanent Staff (EHRA NF)

Director-Regulatory Operations

EHRA Non-Faculty

20051491

NF0008234

Full-Time Permanent

1

40

North Carolina, US

Dependent on Qualifications/Experience

07/22/2024

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.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.

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.

UNC Lineberger Comprehensive Cancer Center (LCCC) oversees and coordinates oncology clinical trial research for UNC School of Medicine and UNC Cancer Care. UNC Lineberger Clinical Research (CR) is responsible for organizing, managing, conducting, and supporting oncology clinical trials. The Director of Regulatory Operations serves as a key member of CR non-faculty leadership overseeing regulatory operations. The regulatory team manages the regulatory oversight of LCCC as a clinical trial site and as an investigator-initiated trial (IIT) sponsor. This position contributes to LCCC CR strategic planning efforts to define and provide adequate oversight to LCCC CR in accordance with the regulatory needs of each type of trial (e.g., basic science, diagnostic, health services, prevent, screening, supportive care, and treatment). The individual is responsible for developing, continually re-evaluating, and maintaining stratified risk-based approaches to regulatory oversight. This position also develops tools and leads process improvement initiatives to improve collaborations with clinical teams desiring centralized regulatory support but maintaining decentralized clinical support. It develops integration methods, communication tools, and oversight mechanisms to ensure compliant and streamlined conduct of clinical research in these decentralized clinical units. This position also contributes to LCCC CR strategic planning deliverables related to timely clinical trial activation. This position aids in strategic planning and implementation of expansion of clinical trial offerings within the UNC Hospital System network by providing advice and developing methods to provide regulatory oversight of the network sites.

This position leads relationships with key UNC partners including, but not limited to, the Office of Human Research Ethics (OHRE) Director, Associate Directors and Chairs, and Central IRB Directors (and partner relationship teams).

This position oversees the regulatory program, leading efforts to streamline regulatory maintenance work to create cost efficient models supporting appropriate regulatory oversight without creating unnecessary oversight layers. This position is responsible for optimizing use of clinical trial systems to facilitate regulatory work including, but not limited to, OnCore, Florence, RedCap, and Microsoft Projects. It co-leads efforts to optimize the hand-offs, communications, and interaction with the clinical operations team. The position develops, optimizes, and maintains workload assessment tools, and designs reports to facilitate forward planning for staffing and optimization of resourcing. This position leads discussions of regulatory issues that are considered in the gray without a black and white solution, providing LCCC CR leadership with measured advice citing applicable regulations and weighing the risk of decisions to allow for informed decision-making.

This position leads training of LCCC investigators and staff on regulatory operations/responsibilities. It develops and maintains standard operating procedures (SOPs), work instructions, and templates for regulatory operations.

The Director leads and maintains processes for assessing site-level compliance with applicable regulations. It is responsible for analyzing data from reports (monitoring, auditing, promptly reportable information (PRI)) and identifying areas of risk and in need of targeted process improvement. This position leads process improvement initiatives to ensure continuing compliance and address areas of non-compliance using standard process improvement methods (e.g., root cause analysis (RCA), A3 and Failure Mode and Effects Analysis (FMEA)). This position designs compliance reports about LCCC as a clinical trial site for executive review. This position serves as the primary point of contact for site-level FDA inspections, leading FDA inspection preparation and response efforts.

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.

In depth knowledge of, and skill in applying applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP), Food and Drug Administration (FDA) regulations and International Conference on Harmonization (ICH) Guidelines. Experience working in oncology clinical trial research.

At least 1-year prior supervisory experience required. Possess excellent interpersonal skills including leadership, team building, motivation, communication, influencing, decision-making, political/cultural awareness, negotiation, trust building, conflict management and coaching. Possess a broad understanding of psychology, human behavior, organizational behavior, interpersonal relations, and communications. Ability to identify, build, maintain, motivate, lead, and inspire teams to achieve high team performance and to meet the project’s objectives. Ability to create an environment that facilitates teamwork. Comfortable interacting with individuals at all levels of the organization including internal and external to UNC Lineberger. Candidate must enjoy working collaboratively with multidisciplinary groups of colleagues. Excellent customer service skills and good judgement required.

Strong organization and problem-solving skills required. Must enjoy leading a team and be able to direct the efforts of the functional group with minimal oversight from senior leadership. Demonstrated ability leading process improvement initiatives. Demonstrated ability analyzing trends and evaluating data to suggest process improvements. Strong software and computer skills, including MS Office applications required.

Demonstrated ability to train and/or teach individuals.

Background in clinical trial site regulatory oversight highly preferred.

Master’s degree of public health (MPH), or science (MS), advanced clinical health science degree or life science PhD or law degree (JD) preferred.

Lean Six Sigma preferred. Previous experience working for a comprehensive cancer center, preferred. Prior experience with OnCore preferred.

Regulatory Affairs Professional Society (RAPS) certification highly preferred. Certified clinical research professional (CCRP) preferred.

Not Applicable.