IRB Director - Research Compliance

Creighton University in Omaha, NE is seeking to hire an IRB Director.

This role provides oversight to all human subjects research performed at Creighton University and its allied Health Care sites; ensuring the protection of subjects' rights, safety, and welfare by helping to foster and maintain a robust human research protection program. Responsible for oversight of both interventional Biomedical related studies and all Social Behavioral studies including student research requirements. This position is also responsible for ensuring that all Federal, state, local, and institutional regulations are followed in human subjects research and for ensuring that all University investigators, faculty, staff and students, are appropriately educated in these regulations and requirements. Maintains accreditations for human subject protections in research at the University and for serving as CU's primary point of contact with federal regulators in this field.

Key Responsibilities

• Provides senior level guidance to all operational aspects of the University's Institutional Review Boards (two separate panels) including hiring and managing the three IRB administrators responsible for preparing, attending, and facilitating board meetings, providing ongoing support and oversight to all research conducted within the University and CHI Health facilities. Responsible for conducting annual evaluations of IRB administrators, Chairs, and Board members.
• Ensure that the continuing education of the IRB Administrators will be performed so that they will advance in the field via the supervision provided. The Director will also ensure that Board members receive ongoing continuing education in order to deepen the knowledge of the Board and promote efficient and compliant IRB review. In addition, they will present lectures to incoming faculty and students to provide ongoing education. Develop and present on IRB topics to faculty, students, Chairs, and members on a regular basis. Facilitate Human Subjects Research training and workshops on a university wide as needed basis and representing Creighton University at regional and national human research protections conferences and symposia.
• Develop, analyze, and implement Creighton University human research protection policies and procedures as federal regulations or relevant accreditation standards evolve. Monitor federal regulatory websites and other research-related resources to stay current with regulatory changes in human research protections guidelines and policies, providing guidance regarding the interpretation of the regulations.
• Maintain and uphold the AAHRRP Accreditation by remaining compliant with AAHRPP organizational standards; ensuring that ethical standards are constantly being met by following written policies and procedures for reviewing the scientific or scholarly validity of proposed research studies. Responsible for complex application processes, metrics of HRPP performance, strategic planning of site visits by accreditors that include preparation and education to university researchers. Maintain Creighton University's Federal Wide Assurance (FWA), ensuring compliance with its terms, as well as Creighton policies and procedures, federal regulations, and state and local laws relative to the conduct of human research studies.
• Oversee the quality assurance monitoring of the HRPP, including research protocols and investigation of matters of non-compliance. Ensure implementation of corrective action, as needed, in accordance with Creighton IRB policies and procedures as well as external audits conducted by federal agencies charged with the oversight of human subject protection and welfare (including FDA and OHRP) at both Creighton's Omaha and Phoenix campuses.
  
  

Qualifications

• Bachelor's Degree in a related field; with a master's degree preferred.
• At least 10 years working experience in a research environment in an Academic Medical Center, institution of higher education, or related field.
• 2+ supervisory years' experience
• CIP certification

Knowledge and Skills

• Deep understanding of and proficiency applying the federal regulations governing human subjects research including 45 CFR 46, 21 CFR parts 50 and 56, and HIPAA;
• Strong knowledge base and working experience in ethics and/or health, law, healthcare administration, research processes and health care settings including regulatory aspects;
• Proficiency skills in MS Office Suite to include Word, Excel, PowerPoint and Outlook;
• Excellent written/verbal communication, interpersonal, and organizational skills;
• Strong collaborative/teamwork ability to motivate, and inspire staff at all levels of the organization;
• Demonstrated experience with strategic thinking and planning;
• Demonstrated ability to develop and implement complex plans coordinated with multiple constituencies;
• Ability to manage, supervise, and develop professional staff;

How to Apply

Applicants are encouraged to apply with a cover letter and up to date resume attached to the online application. If you have any questions submitting your application or materials, please don't hesitate to contact HR@creighton.edu

At Creighton University, you are part of something big. Your skills and passions unite with thousands of faculty, staff and students inspired to change the world. Here, we offer meaningful work driven by a 475-year-old Jesuit tradition committed to social justice and serving others. Through this tradition, we push the boundaries on innovation. We pursue new knowledge for the betterment of society. We seek to improve our world through Catholic and Jesuit values. And it all starts with you.