Director, IRB Compliance

School of Medicine

Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

Be You.

Duke University's School of Medicine (SOM) seeks a Director, Institutional Review Board (IRB) Compliance to support the Human Research Protection Program (HRPP) and IRB mission of safeguarding human research participants. The Director assists in developing the IRB Office/HRPP strategic plan.

Responsibilities include:

• Ensuring compliance with regulations, laws and Institutional/IRB policies.
• Developing policies and procedures and monitoring quality improvement activities.
• Identifying gaps and implementing training needs while serving as a subject matter expert to the HRPP research community.
• As a key member of the IRB Office leadership team, the Director collaborates with research and HRPP leadership, IRB Chairs, and other stakeholders to ensure operational efficiency, compliance and maintenance of AAHRPP accreditation.

Work Arrangement - Hybrid

Anticipated Pay Range

Duke University provides an annual base salary range for this position as USD $ 76,628.00 to USD $153,254.00. Duke University considers factors such as (but not limited to) scope and responsibilities of the position; candidate's work experience, education/training, and key skills; internal peer equity; as well as market and organizational considerations when extending an offer.

PREFERRED QUALIFICATIONS

Master's or doctoral degree in health-related academic field.

Certification as an IRB professional (CIP).

Demonstrated success in managing an IRB/HRPP office, including in a compliance and reliance capacity at a large academic institution, hospital/medical center, academic/independent IrB, or non-profit organization foundation and in making operational improvements to continuously improve the efficency and effectiveness of processes.

Experience with international research standards; or an equivalent combination of education/experience.

Active participation in the community of IRB professionals.

PREFERRED COMPETENCIES (Skills, Knowledge, and Abilities)

Demonstrated expertise, knowledge and experience with the AAHRPP process and requirements.

Expertise in electronic IRB submission systems.

MINIMUM QUALIFICATIONS

Education

Work requires a Bachelor's degree in Business, Public Health or a related field.

Experience

A minimum of seven (7) years of IRB and clinical research experience is required, including managing research studies and working with internal and external reviewing agencies.

This experience should encompass regulatory oversight processes and review boards. The candidate must possess the ability to analyze, understand, and interpret complex policies and federal regulations governing human subjects research.

A Master's degree in Business Administration, Public Health or a related field may be substituted for experience on a 1:1 basis.

Or an Equivalent Combination of Relevant Education and/or Experience.

Be Bold.

Operational Management (65%)

• Manages daily operations of the Compliance team for optimal effectiveness and efficiency.
• Keeps updated on federal regulations, state laws, IRB policies, AAHRPP accreditation requirements, and research trends to identify and implement necessary policy changes.
• Evaluates and improves IRB Office Compliance workflows and processes for efficiency and effectiveness.
• Participates in committees and working groups to provide expertise on federal regulations, state laws, and IRB/HRPP practices.
• Oversees IRB/HRPP electronic systems to ensure compliant and efficient data collection and review processes.
• Collaborates with IRB/HRPP leadership to address non-compliance, complaints, and investigations in human research.
• Ensures Duke University's Federal wide Assurance, IRB Registrations, Rosters, and AAHRPP accreditation remain current, leading the re-accreditation process every five years.
• Improves IRB Office Compliance services and research community engagement through focus groups, advisory committees, and stakeholder communication.
• Manages HRPP quality, post-IRB approval monitoring, audit tracking, and collaborates with IRB leaders for periodic compliance audits.
• Oversees compliance matters, including human research reviews, audits, inspections, systematic reviews, and the investigation and escalation of compliance issues and complaints.
• Regularly exercises sound judgment in answering inquiries impacting human research protocol reviews.
• Leads and advises on regulatory matters, serving as an expert on laws, regulations, and standards, ensuring efficient review and resolution of issues, and providing training.

Training (20%)

• Identifies and directs human research education and training needs, and oversees curriculum development and website content updates.

Reporting and Analysis (10%)

• Generates and reviews IRB metrics reports, analyzes data to improve IRB processes, and collaborates on strategic planning with leadership.

Human Resource Management (5%)

• Supervises and evaluates IRB Office staff, ensuring appropriate organization and staffing.
• Evaluates IRB resources, implements emergency preparedness plans, and manages the budget with the Executive Director.

Performs other duties as assigned.

Choose Duke.

Be a part of the department that safeguards the rights and welfare of human participants involved in research. Additionally, you will benefit from Duke's competitive benefits package, which includes health insurance plans, generous paid time off, retirement programs with employer contributions, tuition assistance for employees and their children, and other unique benefits.

Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.