Director Clinical Research

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Summary:
Oversees the quality, coordination, and conduct of all aspects of clinical research administration to ensure research is
conducted safely, ethically, efficiently, and with the highest integrity. Provides strategic, operational, regulatory, financial, and program leadership for the Heart & Vascular clinical research portfolio. Directs program-level planning, workforce development, and external partnerships to support organizational goals and high-quality clinical research.

Responsibilities:
1. Clinical Research Administration
Exceeds departmental and organizational goals and customer expectations by delivering high quality research operations. Provides direction for the clinical research operation in accordance with ICH GCP guidelines and established regulatory, professional, and organizational standards. Develops, implements, and maintains policies, SOPs, and operational workflows. Ensures IRB policies and procedures are followed. Provides operational and administrative leadership, including oversight of the clinical team and regulatory specialist. Coordinates with ancillary departments (pharmacy, radiology, labs, scheduling, etc.) to ensure efficient daily operations and compliance with institutional and regulatory requirements.
2. Leading People
Leads people toward achieving the organization's vision, mission, and goals. Provides an inclusive workplace that fosters development, teamwork, and constructive conflict resolution. Responsible for efficient staffing to meet research department needs. Oversees hiring, orientation, training, coaching, and evaluation of coworkers to ensure safe, high quality patient care, protection of research subjects, and adherence to UNC Health standards. Delegates assignments, clarifies expectations, and holds others accountable for achieving results. Oversees workforce development, including competency assessment, training initiatives, and ongoing professional development for research staff. Encourages workforce engagement and builds a commitment to excellence.
3. Leading Change
Initiates and manages change to support program growth, operational efficiency, and high quality research. Communicates a compelling vision and need for change that generates excitement, enthusiasm, and commitment. Leads strategic planning and program development, including long term staffing, infrastructure, and resource planning. Identifies new research opportunities and partnerships. Oversees risk identification, mitigation planning, and issue escalation. Serves as a role model for innovation and continuous improvement in organizational performance and clinical research operations.
4. Results Driven
Prepares and maintains accountability for departmental resources and finances. Identifies variances and implements corrective actions. Oversees contract and budget negotiation and execution; serves as primary point of contact for NCHVR contracts. Reviews sponsor protocols to ensure capture of all points of service as they apply to the department and hospital. Determines applicable billable items, appropriate expense reimbursement, and operational cost coverage. Oversees research billing compliance, including review and approval of research patient billing accounts in Epic, Medicare Coverage Analysis (MCA), Medicaid attestation, coding accuracy, and financial reconciliation of charges. Uses financial information to monitor overall financial status and program performance and provides regular updates to leadership.
5. Collaboration & External Relations

Promotes collaboration among physicians, healthcare team members, and other departments to maximize viable clinical trials, improve quality, and enhance participant and physician satisfaction. Works collaboratively with medical staff and departmental representatives to determine study feasibility and guides studies through required processes until trials are approved and opened for enrollment. Ensures active medical staff involvement in identifying clinical trial opportunities and securing participation as principal investigators. Facilitates collaboration with study sponsors and monitors to support ongoing data collection and ensure adherence to contracted timelines and study milestones. Provides study portfolio oversight, including review of feasibility assessments, study selection, activation timelines, and startup processes. Monitors key program metrics such as enrollment, audit outcomes, workload distribution, and financial indicators; attends PSV and SIV meetings. Manages communication and external relations, including interactions with physicians, sponsors, CROs, and institutional partners. Supports sponsor facing business development and relationship management. Provides monthly and quarterly operational reporting and represents the program in institutional and external meetings.

Other Information

Other information:
Education Requirements:
• Bachelor's degree in an appropriate discipline is required. Master's degree preferred.
Licensure/Certification Requirements:
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Professional Experience Requirements:
• • Five years of clinical research experience
• • Three years of management and contract negotiation experience
• • Hospital based cardiovascular research experience preferred
Knowledge/Skills/and Abilities Requirements:
• LANGUAGE SKILLS Ability to read and interpret documents and instructions. Ability to write financial reports and correspondence. Ability to speak effectively with executive staff, department managers and accounting department staff. MATHEMATICAL SKILLS Ability to calculate figures and amounts such as addition, subtraction, percentages, and division. Ability to work with complex formulas, statistical methods, and exponential relationships. Ability to structure mathematical formulas from spoken instructions. REASONING ABILITY Ability to apply principles of logical thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables. Ability to work independent of supervision.

Job Details

Legal Employer: NCHEALTH

Entity: UNC REX Healthcare

Organization Unit: Rex NC HandV Research

Work Type: Full Time

Standard Hours Per Week: 40.00

Pay offers are determined by experience and internal equity

Work Assignment Type: Onsite

Work Schedule: Day Job

Location of Job: US:NC:Raleigh

Exempt From Overtime: Exempt: Yes

This position is employed by NC Health (Rex Healthcare, Inc., d/b/a NC Health), a private, fully-owned subsidiary of UNC Heath Care System. This is not a State employed position.

Qualified applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, genetic information, disability, status as a protected veteran or political affiliation.

UNC Health makes reasonable accommodations for applicants' and employees' religious practices and beliefs, as well as applicants and employees with disabilities. All interested applicants are invited to apply for career opportunities. Please email [click to reveal email address] View email address on us.fitly.work if you need a reasonable accommodation to search and/or to apply for a career opportunity.