*Assistant Director of Human Research Participant Protection (Project Management)

Come join the staff at OU Health Campus in Oklahoma City and become a part of Oklahoma's research university which leads the state in education and career opportunities. OU is one of only four comprehensive academic health centers in the nation with seven professional colleges. we are looking for an Assistant Director of Human Research Participant Protection to join our team.

Responsible for the initiation, development implementation, and evaluation of all compliance, operational, and administrative management activities related to the Human Research Protection Program. Coordinates and manages the comprehensive program for the protection of human participants in research, including ensure the functions, operations, and services of the Institutional Review Board (IRB) are in compliance with federal and state regulations governing human research. Responsible for assisting the Director in the implementation and conduct of the Education and Quality Improvement programs for the protection of human participants in research. 

Duties:

• Provides management and direction of all Institutional Review Boards (IRB). Coordinates all incoming IRB work, with appropriate delegation to IRB staff.
• Supervise IRB Administrators by monitoring performance to ensure quality, efficiency, and adherence to federal regulations, IRB SOPs, AAHRPP standards, and state laws for research are maintained.
• Review draft IRB meeting minutes for accuracy and compliance with federal regulations, IRB SOPs, and AAHRPP standards.
• Acts as a liaison to the IRB Chair(s), committee members, Institutional Official, Organizational Official, faculty and investigators.
• Provides education, training, and guidance to faculty and research staff regarding the protection of human participants in research.
• Provides consultative service on protocols, IRB documents and informed consent documents.
• Provides technical assistance and guidance on the IRB electronic submission system.
• Reviews IRB submissions and all Emergency Use applications for appropriateness and regulatory compliance.
• Assesses each study for disclosure of conflicts of interests and coordinates with the Conflicts of Interest Office.  
• Assists the Director in drafting notices to external agencies regarding reportable events, IRB actions and investigations in consultation with the Office of Compliance and Office of Legal Counsel.
• Assists the Director with development and implementation of IRB policies and procedures (SOPs) that comply with federal regulations, guidance documents, and state laws.
• Monitors IRB staff members, faculty, and research staff for adherence with the IRB SOPs.
• May assist with development of a comprehensive curriculum for training in human research participant protection, GCP, investigator responsibilities, IRB and regulator reporting.
• May conduct workshops and individual training for investigators and staff.
• May assist with the management and conduct of the Quality Improvement Program and with quality improvement audits.
• Makes recommendations for streamlining IRB review process such as revisions to applications, forms, checklists, and templates.
• Makes recommendations for education and training, guidance, policy, and form changes based on feedback, trends, and updates to regulations, policies, and AAHRPP standards.
• Perform various duties as needed to successfully fulfill the functions of the position. 

Required Education: Bachelor's degree. AND:

• 48 months experience directly related to human participant research, IRB, or clinical research.

Equivalency Substitution: Will accept 48 months of related experience in lieu of the bachelor's degree for a total of 96 months of related experience.

Skills:

• Ability to master IRB electronic submission system.
• Demonstrates sound judgement, analytical, organizational, and time management skills. 
• Excellent verbal and written communication skills·    
• Knowledge of HIPAA regulations and state privacy laws relating to human participant research.
• Knowledge of federal regulations for the protection of human participants.       
• Knowledge of Association for the Accreditation of Human Research Protection Programs (AAHRPP) standards and accreditation requirements.
• Ability to interact professionally with all levels of university administration and staff.
• Ability to interpret and apply university policies and procedures.
• Ability to maintain professional standards under non-negotiable time constraints. 

Certifications:

• Certified IRB Professional (CIP) Exam Eligibility will be required after 24 months of service.

Advertised Working Conditions:

• Physical:
  • Sit for prolonged periods.
  • Ability to engage in repetitive motion.
• Environmental:
  • Standard office environment.  
  • Frequent exposure to pressure caused by deadlines and busy periods.

Supervision: Director, Assistant Human Research Participant Protection: 5 employees

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.

Equal Employment Opportunity Statement: The University of Oklahoma, in compliance with all applicable federal and state laws and regulations, does not discriminate based on 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.