Director - Clinical Operations

University of North Carolina, United States

Updated: about 1 year ago
Location: Chapel Hill, NORTH CAROLINA
Job Type: FullTime
Deadline: 02 Feb 2023

Posting Information
Posting Information


Department Lineberger Compr Cancer Center-426801
Career Area Research Professionals
Posting Open Date 01/03/2023
Application Deadline 02/02/2023
Open Until Filled No
Position Type Permanent Staff (EHRA NF)
Working Title Director - Clinical Operations
Appointment Type EHRA Non-Faculty
Position Number 20051489
Vacancy ID NF0006555
Full Time/Part Time Full-Time Permanent
FTE 1
Hours per week 40
Position Location North Carolina, US
Hiring Range Dependent on Qualifications/Experience
Proposed Start Date 04/01/2023

Position Information


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.
Position Summary
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 Clinical Operations serves as a key member of CR non-faculty leadership overseeing clinical operations. This position leads interactions with UNC Hospital/North Carolina Cancer Hospital (NCCH) focusing on clinical research integration and compliance and leads process improvement initiatives to optimize the interactions between Hospital and LCCC CR infrastructure. This individual contributes to LCCC CR strategic planning deliverables related to establishing a process for ongoing feedback, input, and support to align LCCC CR strategy with UNC Hospital clinical strategic trajectory. This individual leads collaborations with non-centralized oncology clinical research units to ensure efficient interactions with UNC Hospital/ NCCH and consistent clinical trial conduct within NCCH. This individual leads efforts to standardize conduct of treatment and non-treatment trials, as appropriate and devises and maintains a risk-based approach to clinical oversight of different trial types. This position leads clinical research infrastructure expansion into offsite Cancer Clinics, such as UNC Eastowne and Hillsborough. This position leads process improvement initiatives to optimize clinical research within these offsite locations and communications between main UNC Hospital clinical research and research conducted at the offsite locations. Furthermore, this position aids in strategic planning and implementation of expansion of clinical trial offerings to other UNC Healthcare System network sites. 
This position leads key collaborations with NC Cancer Hospital management to optimize clinical research integration, ensure clinical research compliance and initiate forward planning in response to UNC Hospital-directed changes. 
The Director of Clinical Operations leads LCCC CR strategic planning deliverables related to clinical trial accrual. The position will collaborate with community outreach and engagement (COE) leads and the lay navigator (who provides clinical trial education) on accrual efforts. This includes leading process improvement initiatives to improve clinical research accrual such as efforts focused on optimization of the use of clinical staff bandwidth, screening efforts, recruitment efforts, publicization of available clinical trial efforts and diverse patient recruitment efforts. This individual analyzes data and presents dashboards and/or reports to LCCC CR leadership on analytic cases versus clinical trial enrollment overall and by disease group over time, and enrollment of diverse patient populations. This individual aids disease group leaders with portfolio management, aiding in selection of clinical trials that address unmet patient needs based on analysis of the catchment area versus actual accrual metrics. This position forward-plans for staffing within disease groups based on accrual potential, historical accrual, increases in analytic cases, staff attrition rates and activation of new clinical trials, and leads budgeting of clinical operations staff to ensure that costs are covered by revenue. 
This position leads training of LCCC investigators and staff on clinical operations, including onboarding new clinical researchers by prompting proper engagement of study coordinators. This position develops vs oversees standard operating procedures (SOPs), work instructions, and templates for clinical operations. This individual leads daily clinical operation compliance to ensure patient safety and data integrity including leading compliance process improvement initiatives.
Minimum Education and Experience Requirements
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, Competencies, and Experience
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.
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. 
Previous experience working in clinical research at an academic medical center, or similar, required. 
Demonstrated ability to train and/or teach individuals.
Preferred Qualifications, Competencies, and Experience
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. 3+ 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.
Special Physical/Mental Requirements
Campus Security Authority Responsibilities

Not Applicable.
Special Instructions
Quick Link https://unc.peopleadmin.com/postings/247019

Posting Contact Information


Department Contact Name and Title Gretchen Harrison, Human Resources Consultant
Department Contact Telephone or Email [email protected]
Office of Human Resources Contact Information

If you experience any problems accessing the system or have questions about the application process, please contact the Office of Human Resources at (919) 843-2300 or send an email to [email protected]
Please note: The Office of Human Resources will not be able to provide specific updates regarding position or application status.
Equal Opportunity Employer Statement
The University of North Carolina at Chapel Hill is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or status as a protected veteran.

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