IRB Director - Research Compliance

Creighton University - Omaha, NE

Full-time - Senior

Omaha, NE

Educational Services

About the position

The IRB Director at Creighton University is responsible for overseeing all human subjects research conducted at the university and its affiliated healthcare sites. This role ensures the protection of subjects' rights, safety, and welfare by maintaining a robust human research protection program. The director will manage the Institutional Review Boards (IRBs), ensure compliance with federal and state regulations, and provide education to faculty, staff, and students regarding human subjects research requirements.

Responsibilities

• Provide senior level guidance to all operational aspects of the University's Institutional Review Boards (two separate panels).
• Hire and manage the three IRB administrators responsible for preparing, attending, and facilitating board meetings.
• Conduct annual evaluations of IRB administrators, Chairs, and Board members.
• Ensure continuing education for IRB Administrators and Board members to deepen their knowledge and promote efficient IRB review.
• Present lectures to incoming faculty and students on IRB topics.
• Facilitate Human Subjects Research training and workshops on a university-wide basis.
• Develop, analyze, and implement human research protection policies and procedures as regulations evolve.
• Monitor federal regulatory websites to stay current with regulatory changes in human research protections guidelines and policies.
• Maintain and uphold the AAHRRP Accreditation by ensuring compliance with organizational standards.
• Oversee the quality assurance monitoring of the HRPP, including research protocols and investigation of non-compliance matters.

Requirements

• Bachelor's Degree in a related field; Master's degree preferred.
• At least 10 years of working experience in a research environment in an Academic Medical Center or related field.
• 2+ years of supervisory experience.
• CIP certification.
• Deep understanding of federal regulations governing human subjects research including 45 CFR 46, 21 CFR parts 50 and 56, and HIPAA.
• Strong knowledge base in ethics, healthcare administration, and research processes.

Nice-to-haves

• Proficiency in MS Office Suite including Word, Excel, PowerPoint, and Outlook.
• Excellent written/verbal communication, interpersonal, and organizational skills.
• Strong collaborative/teamwork ability to motivate and inspire staff.
• Demonstrated experience with strategic thinking and planning.

Benefits

• Health insurance
• Dental insurance
• Retirement savings plan
• Paid holidays
• Professional development opportunities