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

 

1. Master’s or doctoral degree in health-related academic field.
2. Certification as an IRB professional (CIP).
3. 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.
4. Experience with international research standards; or an equivalent combination of education/experience.
5. Active participation in the community of IRB professionals.

 

PREFERRED COMPETENCIES (Skills, Knowledge, and Abilities)

 

1. Demonstrated expertise, knowledge and experience with the AAHRPP process and requirements.
2. 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.