Associate Director-Institutional Review Board (IRB)

Market Range: 15      

Hiring Salary: $6,674.01 - $9,107.96/Monthly

JOB SUMMARY/ESSENTIAL JOB FUNCTIONS: The Associate Director works closely with the Director and Chairs to assist in the coordination and management of the Institutional Review Board (IRB) to ensure that the functions, operations, and services of the IRB are in compliance with federal, state, and university regulations and policies governing all human subject research.  In addition, training, supervising, reviewing the work of IRB staff, and establishing work priorities and deadlines. This position develops and conducts education and training programs for researchers, board members, and staff.

1. Serves as a voting member of the IRB; attends weekly IRB meetings and ensures the meetings are conducted and that the comprehensive documentation of IRB actions are in compliance with federal regulations. 
2. Screens research applications to determine whether additional information is required; completes comprehensive reviews of extremely complicated scientific research proposals and accompanying documents to identify regulatory issues as well as institutional policy issues and makes recommendations. 
3. Communicates concerns to research staff (investigators and/or coordinators) to resolve pertinent issues and approve administrative and procedural modifications. 
4. Reviews responsive materials from investigators and determines whether stated conditions have been satisfied or whether further review by the IRB at a subsequent convened meeting is necessary; reviews comprehensive documentation of IRB actions and applicable regulations and notify the IRB Director of any corrections or additions. 
5. Analyzes and facilitates the review and approval of non-research requests for the use of drugs, biologics or devices under federal regulations pertaining to Emergency Use, Compassionate Use/Treatment Use, and Humanitarian Use Devices. 
6. Develops and maintains information and resources for the IRB webpage; provides recommendations and assists with the design, testing, and management of the IRB electronic system, iMedRIS.
7. Acts as liaison with faculty and research coordinators; provides technical assistance and guidance on human research participation protection; acts as liaison between the IRB Chair, IRB members and research staff (investigators/coordinators); coordinates IRB matters with affiliated institutions and other external institutions. 
8. Directs the administrative staff concerning department guidelines, regulatory or policy changes; assists in supervising the work of IRB staff; monitors their progress and provides timely feedback on their performance.
9. Provides regulatory, ethical and method advice to research staff, investigators/coordinators) engaged in research involving human subjects to ensure compliance with federal, state and university policies and procedures. 
10. Develops and provides training and assistance to IRB staff; identifies focal topics for IRB and iMedRIS training for researchers and develops content for training materials and presentations; provides, develops, and conducts individual and departmental training programs regarding IRB electronic system and the IRB process. 
11. Provides consultation, special presentations, and assistance to departments, classes, and other interest groups including a wide array of UTHSC researchers (faculty, staff, and students), IRB members and staff about regulatory, ethical and methodological issues in human research ethical IRB policies and procedures. 
12. Perform other duties as required.   

MINIMUM REQUIREMENTS:  

EDUCATION: Master’s Degree. (TRANSCRIPT REQUIRED)

EXPERIENCE: Three (3) years of experience in university administration with experience directly related to human subject research. Completed certification as IRB Professional (CIP).  Must possess previously demonstrated working knowledge of human subjects’ protection regulations and ethical standards as well as the demonstrated ability to analyze and apply regulations and ethical codes.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Experience in a research environment that demonstrates work with compliance issues and familiarity with research ethics and methods. 
• Analytical and problem-solving abilities to include skill in making effective recommendations and decisions.
• Ability to use multiple resources and references to understand complex regulations. 
• Strong organizational skills and the ability to multitask and problem-solve with high volumes and rigid deadlines. 
• Must be proficient in the use of the compu