The University of North Carolina at Chapel Hill · 12 hours ago
Assistant Director - Clinical Operations
Chapel Hill, NC
Full-time
Onsite
Lead/Staff, Director/Executive
3+ years expThe University of North Carolina at Chapel Hill is a leading institution in higher education known for its commitment to research and public service. The Assistant Director of Clinical Operations will oversee the clinical operations of oncology research studies, focusing on strategic planning, process improvement, and collaboration with various teams to enhance clinical trial accrual and operational efficiency.
EducationHigher EducationUniversities
Responsibilities
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
Lead collaborations with key teams including other functional groups, translational core facilities, and UNC correlative laboratories
Lead training of LCCC investigators and staff on clinical operations for clinical trials
Develop and maintain standard operating procedures (SOPs), work instructions, and templates for clinical trials
Provide training and ongoing mentorship to help the leaders and staff within the unit reach their full potential
Responsible for recruiting appropriate individuals for the right roles
Lead the building of a culture of trust, empathy, collaboration, and accountability within the unit
Steer and monitor the direction, goals, and needs of the clinical operations unit charged with overseeing clinical translational research
Oversee capacity planning and determine staffing levels needed to successfully deliver compliant services
Lead development and maintenance of a standardized clinical trial complexity tool for workload planning
Troubleshoot all operational issues and optimize efficiencies by identifying areas of need and leading process improvement initiatives
Collaborate with investigators and core facility directors to identify needs, develop expertise, improve operational capacity, and refine/develop/expand services offered
Develop and maintain systems to oversee compliance of clinical research studies that do not qualify based on risk for monitoring and/or auditing
Monitor the clinical research portfolio and trial progress relative to established timelines and contractual obligations, facilitating timely resolution of sponsor concerns
Implement report out systems on the clinical portfolio, academic impact/productivity, financial status, and staffing
Lead process improvement initiatives to optimize the interactions between UNC Hospital and LCCC CR infrastructure to facilitate operations of clinical trials
Aid with clinical research infrastructure expansion into offsite Cancer Clinics and UNC Hospital System network sites
Oversee the operating budget of the clinical unit overseeing clinical research
Collaborate with the Director, Clinical Trial Activation to develop and continually refine cost structures and budget assumptions for clinical study operations
Assist with budget development for clinical operations budgets
Additional duties as needed
Qualification
Required
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
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
Preferred
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
Benefits
Comprehensive benefits package
Paid leave
Variety of health, life and retirement plans
Programs that support a healthy work/life balance
Company
The University of North Carolina at Chapel Hill
Carolina’s vibrant people and programs attest to the University’s long-standing place among leaders in higher education since it was chartered in 1789 and opened its doors for students in 1795 as the nation’s first public university.
10001+ employees
H1B Sponsorship
The University of North Carolina at Chapel Hill has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (165)
2024 (143)
2023 (100)
2022 (133)
2021 (83)
2020 (89)
Funding
Current Stage
Late StageTotal Funding
$48.57MKey Investors
SECU FoundationCDA FoundationNorth Carolina Biotechnology Center
2024-07-19Grant· $1M
2024-03-18Grant
2023-02-16Grant· $0.11M
Leadership Team
Judith Cone
Retired Vice Chancellor for Innovation, Entrepreneurship and Innovation as of April 1, 2021
Michael Williams
Network SEcurity Team Lead
Recent News
Morningstar.com
2025-09-20
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