Assistant Director - Clinical Operations

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 Lineberger Comprehensive Cancer Center, founded in 1975, is a National Cancer Institute ( NCI)-designated comprehensive cancer center. The Center's mission is to reduce cancer occurrence and death in North Carolina and the nation through research, treatment, training, and outreach. UNC Lineberger's Clinical Research is a centralized resource that supports the clinical research efforts of Lineberger investigators, primarily through the design and conduct of therapeutic clinical trials. Clinical Research provides administrative, regulatory, data management, and study coordination services to investigators throughout the development, approval, and implementation processes of protocols conducted at UNC and its affiliate institutions. Clinical Operations is responsible for protecting the safety of patients participating in research, ensuring the quality of the research, and safeguarding the interests of the University. It also furnishes protocol-related information to health professionals and to the community at large.

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 Assistant Director of Clinical Operations serves as a key member of Clinical Research non-faculty leadership overseeing the clinical operations of oncology research studies. Responsible for LCCC Clinical Research strategic planning deliverables related to clinical trial accruals leading to process improvement initiatives to increase clinical research accrual such as efforts focused on optimization of the use of clinical staff bandwidth, screening efforts, recruitment efforts, publicization of available clinical trials and diverse patient recruitment efforts.
This position leads collaborations with key teams including other functional groups (e.g., Regulatory, Sponsor Operations), translational core facilities, and UNC correlative laboratories. This position leads training of LCCC investigators and staff on clinical operations for clinical trials and develops and maintains standard operating procedures (SOPs), work instructions, and templates for clinical trials.
This position provides training and on-going mentorship to help the leaders and staff within the unit reach their full potential. It is responsible for recruiting appropriate individuals for the right roles, recognizing the need for talents and passions to collide. This position leads the building of a culture of trust, empathy, collaboration, and accountability within the unit.
This position continually steers and monitors the direction, goals, and needs of the clinical operations unit charged with overseeing clinical translational research. It oversees capacity planning and determines staffing levels needed to successfully deliver compliant services. This position leads development and maintenance of a standardized clinical trial complexity tool for workload planning (e.g., OPAL). This individual leads and continually re-evaluates the clinical operations research career ladder. This individual troubleshoots all operational issues and optimizes efficiencies by identifying areas of need and leading process improvement initiatives. It collaborates with investigators and core facility directors to identify needs, develop expertise, improve operational capacity, and refine/develop/expand services offered. This position develops and maintains systems to oversee compliance of clinical research studies that do not qualify based on risk for monitoring and/or auditing. It monitors the clinical research portfolio and trial progress relative to established timelines and contractual obligations, facilitating timely resolution of sponsor concerns. The position is responsible for implementing report out systems on the clinical portfolio, academic impact/productivity, financial status, and staffing.
This position leads process improvement initiatives to optimize the interactions between UNC Hospital and LCCC CR infrastructure to facilitate operations of clinical trials. It aids with clinical research infrastructure expansion into offsite Cancer Clinics and UNC Hospital System network sites.
This individual is responsible for overseeing the operating budget of the clinical unit overseeing clinical research. This individual collaborates with the Director, Clinical Trial Activation to develop and continually refine cost structures and budget assumptions for clinical study operations, providing guidance and direction in negotiation of scope of work, timelines, budgets, and payment schedules. This individual assists with budget development for clinical operations budgets. Additional duties as needed.

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.

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.

Previous experience working in clinical research at an academic medical center, or similar, required.

Demonstrated ability to train and/or teach individuals.

Background in oncology clinical research highly preferred.

Master's degree of public health ( MPH), business ( MBA), or science (MS), advanced clinical health science degree or life science PhD preferred. 2+ years of prior supervisory experience preferred.

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

Certified clinical research professional ( CCRP) or similar, preferred.

The University is an equal opportunity employer and welcomes all to apply without regard to age, color, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, or sexual orientation. We encourage all qualified applicants to apply, including protected veterans and individuals with disabilities.