Assistant Director - Clinical Operations
The University of North Carolina at Chapel Hill, Raleigh, North Carolina, United States
Overview
Posting Information Department: Lineberger Compr Cancer Center-426801 Career Area: Research Professionals Posting Open Date: 03/27/2025 Application Deadline: 02/23/2026 Open Until Filled: No Position Type: Permanent Staff (EHRA NF) Working Title: Assistant Director - Clinical Operations Appointment Type: EHRA Non-Faculty Position Number: 20051707 Vacancy ID: NF0009053 Full Time/Part Time: Full-Time Permanent FTE: 1 Hours per week: 40 Position Location: North Carolina, US Qualifications: Hiring Range Salary commensurate with qualifications. Proposed Start Date: 04/21/2025 Position Information
Be a Tar Heel! 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. UNC-Chapel Hill offers 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. Primary Purpose Of Organizational Unit: The UNC Lineberger Comprehensive Cancer Center (LCCC) is an NCI-designated comprehensive cancer center. Clinical Research supports the clinical research efforts of Lineberger investigators, primarily through therapeutic clinical trials. Clinical Operations protects patient safety, ensures research quality, and safeguards University interests, furnishing protocol-related information to health professionals and the community. Position Summary
UNC Lineberger Comprehensive Cancer Center oversees and coordinates oncology clinical trial research for UNC School of Medicine and UNC Cancer Care. UNC Lineberger Clinical Research is responsible for organizing, managing, conducting, and supporting oncology clinical trials. The Assistant Director of Clinical Operations serves as a key non-faculty leader overseeing the clinical operations of oncology research studies. Responsible for LCCC Clinical Research strategic planning deliverables related to clinical trial accruals and process improvement initiatives to increase accrual, including optimization of clinical staff bandwidth, screening, recruitment, publicizing available clinical trials, and diverse patient recruitment efforts. This position leads collaborations with key teams (e.g., Regulatory, Sponsor Operations), translational core facilities, and UNC correlative laboratories. It leads training of LCCC investigators and staff on clinical operations for clinical trials and develops and maintains SOPs, work instructions, and templates for clinical trials. It provides training and ongoing mentorship to help leaders and staff reach their full potential. It is responsible for recruiting appropriate individuals for the right roles, and for building a culture of trust, empathy, collaboration, and accountability within the unit. This position directs the clinical operations unit to oversee clinical translational research, capacity planning, and staffing levels. It leads development and maintenance of a standardized clinical trial complexity tool for workload planning (e.g., OPAL). It leads and reevaluates the clinical operations research career ladder. It troubleshoots operational issues and leads process improvement initiatives. It collaborates with investigators and core facility directors to identify needs, develop expertise, improve capacity, and refine services. It develops and maintains systems to oversee compliance of studies that do not qualify for monitoring/auditing. It monitors the clinical research portfolio and trial progress relative to timelines and obligations, facilitating sponsor issue resolution. It implements report-out systems on portfolio, impact, financial status, and staffing. This role leads process improvement to optimize UNC Hospital and LCCC CR infrastructure interactions to support clinical trials, and contributes to infrastructure expansion into offsite Cancer Clinics and UNC Hospital System sites. Oversees the operating budget of the clinical unit, collaborates with the Director, Clinical Trial Activation to refine cost structures and budgets, and provides guidance on scope, timelines, budgets, and payment schedules. Assists with budget development for clinical operations. Additional duties as needed. Minimum Education And Experience
Relevant post-Baccalaureate degree required (or foreign degree equivalent); for candidates with comparable independent research productivity, a relevant Bachelor’s degree (or foreign degree equivalent) and 3+ years of relevant experience may be substituted. May require terminal degree and licensure. Required Qualifications, Competencies, And Experience
In-depth knowledge of clinical research regulatory requirements (GCP, FDA regulations, ICH Guidelines). Prior supervisory experience. Excellent interpersonal skills including leadership, team building, motivation, communication, influencing, decision-making, cultural awareness, negotiation, trust building, conflict management, and coaching. Ability to lead diverse teams, facilitate collaboration, and deliver high performance with minimal oversight. Strong client service, judgment, and ability to interact with all organizational levels. Proficiency with MS Office and strong organizational and problem-solving skills. Previous experience in clinical research at an academic medical center or similar setting. Demonstrated ability to train and/or teach individuals. Preferred Qualifications
Background in oncology clinical research preferred. Master’s degree (MPH, MBA, MS) or related clinical health science PhD; 2+ years of supervisory experience preferred. Lean Six Sigma certification preferred. Experience with OnCore and working for a comprehensive cancer center preferred. CCRP or similar certification preferred. Special Instructions and Contacts
Quick Link: https://unc.peopleadmin.com/postings/298795 Posting Contact Information: Department Contact: Gretchen Harrison; Email: gretchen_harrison@med.unc.edu Office of Human Resources: For system access issues or application questions, contact 919-843-2300 or employment@unc.edu. The Office of Human Resources will not provide position or status updates. Equal Opportunity Employer Statement: 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, including protected veterans and individuals with disabilities.
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Posting Information Department: Lineberger Compr Cancer Center-426801 Career Area: Research Professionals Posting Open Date: 03/27/2025 Application Deadline: 02/23/2026 Open Until Filled: No Position Type: Permanent Staff (EHRA NF) Working Title: Assistant Director - Clinical Operations Appointment Type: EHRA Non-Faculty Position Number: 20051707 Vacancy ID: NF0009053 Full Time/Part Time: Full-Time Permanent FTE: 1 Hours per week: 40 Position Location: North Carolina, US Qualifications: Hiring Range Salary commensurate with qualifications. Proposed Start Date: 04/21/2025 Position Information
Be a Tar Heel! 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. UNC-Chapel Hill offers 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. Primary Purpose Of Organizational Unit: The UNC Lineberger Comprehensive Cancer Center (LCCC) is an NCI-designated comprehensive cancer center. Clinical Research supports the clinical research efforts of Lineberger investigators, primarily through therapeutic clinical trials. Clinical Operations protects patient safety, ensures research quality, and safeguards University interests, furnishing protocol-related information to health professionals and the community. Position Summary
UNC Lineberger Comprehensive Cancer Center oversees and coordinates oncology clinical trial research for UNC School of Medicine and UNC Cancer Care. UNC Lineberger Clinical Research is responsible for organizing, managing, conducting, and supporting oncology clinical trials. The Assistant Director of Clinical Operations serves as a key non-faculty leader overseeing the clinical operations of oncology research studies. Responsible for LCCC Clinical Research strategic planning deliverables related to clinical trial accruals and process improvement initiatives to increase accrual, including optimization of clinical staff bandwidth, screening, recruitment, publicizing available clinical trials, and diverse patient recruitment efforts. This position leads collaborations with key teams (e.g., Regulatory, Sponsor Operations), translational core facilities, and UNC correlative laboratories. It leads training of LCCC investigators and staff on clinical operations for clinical trials and develops and maintains SOPs, work instructions, and templates for clinical trials. It provides training and ongoing mentorship to help leaders and staff reach their full potential. It is responsible for recruiting appropriate individuals for the right roles, and for building a culture of trust, empathy, collaboration, and accountability within the unit. This position directs the clinical operations unit to oversee clinical translational research, capacity planning, and staffing levels. It leads development and maintenance of a standardized clinical trial complexity tool for workload planning (e.g., OPAL). It leads and reevaluates the clinical operations research career ladder. It troubleshoots operational issues and leads process improvement initiatives. It collaborates with investigators and core facility directors to identify needs, develop expertise, improve capacity, and refine services. It develops and maintains systems to oversee compliance of studies that do not qualify for monitoring/auditing. It monitors the clinical research portfolio and trial progress relative to timelines and obligations, facilitating sponsor issue resolution. It implements report-out systems on portfolio, impact, financial status, and staffing. This role leads process improvement to optimize UNC Hospital and LCCC CR infrastructure interactions to support clinical trials, and contributes to infrastructure expansion into offsite Cancer Clinics and UNC Hospital System sites. Oversees the operating budget of the clinical unit, collaborates with the Director, Clinical Trial Activation to refine cost structures and budgets, and provides guidance on scope, timelines, budgets, and payment schedules. Assists with budget development for clinical operations. Additional duties as needed. Minimum Education And Experience
Relevant post-Baccalaureate degree required (or foreign degree equivalent); for candidates with comparable independent research productivity, a relevant Bachelor’s degree (or foreign degree equivalent) and 3+ years of relevant experience may be substituted. May require terminal degree and licensure. Required Qualifications, Competencies, And Experience
In-depth knowledge of clinical research regulatory requirements (GCP, FDA regulations, ICH Guidelines). Prior supervisory experience. Excellent interpersonal skills including leadership, team building, motivation, communication, influencing, decision-making, cultural awareness, negotiation, trust building, conflict management, and coaching. Ability to lead diverse teams, facilitate collaboration, and deliver high performance with minimal oversight. Strong client service, judgment, and ability to interact with all organizational levels. Proficiency with MS Office and strong organizational and problem-solving skills. Previous experience in clinical research at an academic medical center or similar setting. Demonstrated ability to train and/or teach individuals. Preferred Qualifications
Background in oncology clinical research preferred. Master’s degree (MPH, MBA, MS) or related clinical health science PhD; 2+ years of supervisory experience preferred. Lean Six Sigma certification preferred. Experience with OnCore and working for a comprehensive cancer center preferred. CCRP or similar certification preferred. Special Instructions and Contacts
Quick Link: https://unc.peopleadmin.com/postings/298795 Posting Contact Information: Department Contact: Gretchen Harrison; Email: gretchen_harrison@med.unc.edu Office of Human Resources: For system access issues or application questions, contact 919-843-2300 or employment@unc.edu. The Office of Human Resources will not provide position or status updates. Equal Opportunity Employer Statement: 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, including protected veterans and individuals with disabilities.
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