Assistant Director - Clinical Operations

UNC-Chapel Hill • Chapel Hill, NC

6d

About The Position

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 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.

Requirements

• 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.

Nice To Haves

• 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.

Responsibilities

• LCCC Clinical Research strategic planning deliverables related to clinical trial accruals leading to process improvement initiatives to increase clinical research accrual
• Leads collaborations with key teams including other functional groups (e.g., Regulatory, Sponsor Operations), translational core facilities, and UNC correlative laboratories.
• 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.
• Provides training and on-going mentorship to help the leaders and staff within the unit reach their full potential.
• Responsible for recruiting appropriate individuals for the right roles
• Leads the building of a culture of trust, empathy, collaboration, and accountability within the unit.
• Continually steers and monitors the direction, goals, and needs of the clinical operations unit charged with overseeing clinical translational research.
• Oversees capacity planning and determines staffing levels needed to successfully deliver compliant services.
• Leads development and maintenance of a standardized clinical trial complexity tool for workload planning (e.g., OPAL ).
• Continually re-evaluates the clinical operations research career ladder.
• Troubleshoots all operational issues and optimizes efficiencies by identifying areas of need and leading process improvement initiatives.
• Collaborates with investigators and core facility directors to identify needs, develop expertise, improve operational capacity, and refine/develop/expand services offered.
• Develops and maintains systems to oversee compliance of clinical research studies that do not qualify based on risk for monitoring and/or auditing.
• Monitors the clinical research portfolio and trial progress relative to established timelines and contractual obligations, facilitating timely resolution of sponsor concerns.
• Responsible for implementing report out systems on the clinical portfolio, academic impact/productivity, financial status, and staffing.
• Leads process improvement initiatives to optimize the interactions between UNC Hospital and LCCC CR infrastructure to facilitate operations of clinical trials.
• Aids with clinical research infrastructure expansion into offsite Cancer Clinics and UNC Hospital System network sites.
• Responsible for overseeing the operating budget of the clinical unit overseeing clinical research.
• 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.
• Assists with budget development for clinical operations budgets.
• Additional duties as needed.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 11-50 employees