IRB Administrator (Project Management)

The Institutional Review Boards (IRB) for the OUHSC campus is responsible for reviewing research submissions that involve human subjects and assess that it adequately meets the criteria for approval set forth by the federal regulations, state law, and OU policies and procedures. Provides administrative support to the Institutional Review Board by assisting with submission and review coordination. Provides technical assistance to investigators involved in human subjects research. Provides recommendations for improving the IRB review process.

Duties:  

• Assists investigators with the application submission process. Interprets and advises investigators on applicable policies, procedures, guidelines, federal regulations, and other compliance related requirements.
• Answers various questions and may guide investigators through some processes.
• Screens research study applications to determine completeness and accuracy.
• Determines if studies meet review criteria for exempt, expedited, or full board by reviewing the IRB application, protocol and consent forms, ensuring they receive appropriate review according to federal regulations.
• Screens revised applications and resubmissions, reviews changes, and if acceptable, forwards to IRB Chairperson for final approval.  
• Establishes record of incoming mail into IRB database.
• Distributes exempt and expedited studies to IRB Chairperson for review.
• Coordinates with principal investigators for preparation of material for board meetings.
• Generates correspondence on behalf of Director, Assistant Director, and/or IRB Chairpersons.  
• Stamps consent forms appropriately. Distributes correspondence to Investigators.
• Liaison between the IRB, the IRB Chairperson, Investigators, Office of Research Administration (ORA), Radiation Safety Office, and the Institutional Bio-safety Committee.
• Responsible for following up with investigators to ensure they are aware of time limits and deadlines. 
• Coordinates and schedules monthly reviews and annual review reports with the Institutional Review Boards (IRB).
• Creates agenda, and ensures there is an appropriate composition of members to make quorum according to federal regulations. Ensures proper procedures are followed.
• Creates board letters with instructions for corrections based on deliberations at the meeting.
• Takes minutes, prepares written draft, and distributes to the IRB Chairperson as required.   
• Makes recommendations for streamlining IRB review process such as the revision of applications and consent forms, investigator notification, prior categorization and assignment of application submitted for board review.
• Performs various duties as needed to successfully fulfill the function of the position.

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.

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.
• Excellent writing skills necessary for communication stipulations to investigators and writing meeting minutes each month. 
• Proficient in Microsoft Office.

Certifications:

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

Working Conditions:

• Physical: Must be able to work in sitting position. Ability to engage in repetitive motion.
• Environmental: Standard Office Work Environment.

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