Responsible for the initiation, development implementation, and evaluation of all compliance, operational, and administrative management activities related to the Human Research Protection Program which includes ensuring that the functions, operations and services of the Institutional Review Board (IRB) are in compliance with Federal and State regulations governing human research. Implements and conducts of the Education and Quality Improvement programs for the protection of human participants in research.

Duties:

• Directs the comprehensive program for the protection of human participants in research to include training, good clinical practice (GCP), investigator responsibilities, IRB, and regulatory reporting, offered as required by leadership.


• Directs the function, office operations, and services of the Institutional Review Board (IRB), ensuring compliance with applicable regulations governing human participant research by maintaining library resources of IRB rules and regulations, revising and updating IRP policies, procedures and guidelines by serving as a liaison between the IRB Chair, committee members and investigators.


• Oversees the development and implementation of the education program and the Quality Improvement program for the protection of human participants in research including internal HRPP and IRB monitoring, post-approval monitoring of research under the oversight of the and other designated IRBs, and periodic AAHRPP self-assessments.


• Provides consultative services and guidance to faculty, research staff and other University departments regarding protection of human participants in research by consulting with faculty Principal Investigators on IRB applications, protocols, and informed consent documents, to assure compliance with federal, state and university policies, regulations, and guidelines. 


• Interacts with Internal Committees, and with External Agencies and Organizations by coordinating IRB matters between the University and federal agencies, Oklahoma Health Center Organizations pharmaceutical or other sponsors of research, regional research coordinators, and other affiliated institutions.


• Provides information about the program, record keeping of researcher and research staff training and certification, attending education programs, remains current on federal and state legislation, and incorporates all relevant information into curriculum.


• Supervises assigned departmental staff.


• Performs other duties as assigned.

Required Education: Bachelor's degree in a related field, AND:

• 36 months experience in any combination of the following areas:  IRB administration, grant and contract administration, clinical research administration, or clinical research nursing administration to include 12 months IRB experience.

Equivalency/Substitution: Experience or a combination of education & related experience can be considered in lieu of degree. A one-to-one ratio is used to determine the number of years of experience required in place of a degree. 

Skills:

• Excellent interpersonal skills


• Able to communicate well and build rapport quickly with students, faculty and staff


• Detailed oriented for accuracy of data and information 


• Proficient in Microsoft Office

Certifications:

• Take Certified IRB Professional (CIP) Exam after 2 years IRB experience

Advertised Physical Requirements:

• 
  Physical:
  
  
  • Must be able to work in sitting position. 
  
  
  • Ability to engage in repetitive motion.
  
  
  
  


• 
  Environmental:
  
  
  
  • Standard Office Work Environment.
  
  
  
  

Equal Employment Opportunity Statement:  The University of Oklahoma, in compliance with all applicable federal and state laws and regulations, does not discriminate on the basis of race, color, national origin, sex, sexual orientation, genetic information, gender identity, gender expression, age, religion, disability, political beliefs, or status as a veteran in any of its policies, practices, or procedures. This includes, but is not limited to, admissions, employment, financial aid, housing, services in educational programs or activities, and health care services that the University operates or provides.

Why You Belong at the University of Oklahoma: The University of Oklahoma, fosters an inclusive culture of respect and civility, belonging, and access, which are essential to our collective pursuit of excellence and our determination to change lives. The unique talents, perspectives, and experiences of our community enrich the learning, and working environment at OU, inspiring us to harness our innovation, creativity, and collaboration for the advancement of people everywhere.