Market Range:12

Salary Commensurate with Education and Experience

JOB SUMMARY/ESSENTIAL JOB FUNCTIONS: The IRB Director is responsible for implementing IRB policy and procedure, federal and state statutes, and regulations on the protection of human subjects for the UTGSM and affiliated institutions. The Director ensures that human subjects' research is reviewed and approved in accordance with appropriate international, federal or state regulations and guidance. This position is responsible for maintaining efficient and compliant processes for the review, approval and oversight of human subjects' research performed by the IRB at UTGSM. The Director manages the IRB office staff and provides assistance and guidance to researchers on campus. This position is responsible for the development of IRB training programs for faculty, students and staff conducting human subjects' research.

DUTIES AND RESPONSIBILITIES:

1. Serves as the chief administrative and programmatic support for the IRB; provides consultation, assistance, and dissemination of the information regarding the review process of the IRB office.
2. Develops, implements, and evaluates standard operating procedures (SOPs) to ensure compliance with federal regulatory requirements.
3. Develops guides to improve communication and understanding of human research requirements.
4. Oversees the development and implementation of educational activities, training programs and materials, and web sites for faculty, research teams and support staff, IRB members, UTGSM IRB staff and community research.
5. Manages budget and invoice, receive and manage all IRB accounts receivable.
6. Assists the Chair in reviewing serious adverse events, Safety Alerts, MedWatch, protocol deviations, unexpected problems or unanticipated risks to subjects or others, injury to subjects, complaints or reports of noncompliance.
7. Supervises and coaches IRB administrative staff, including development and updating of job descriptions, interviewing, selection, training, performance evaluation, promotion and disciplinary action; establishes work priorities and deadlines.
8. Consults with grant and contract services regarding compliance on new, continuing review, and competing proposals with human subjects' regulations and policy.
9. Represents UTGSM at site inspections, regulatory visits, and meetings with sponsors, OHRP or FDA; and develop, update and implement procedures for managing and responding to federal regulatory authorities, sponsors, and institutional officials.
10. Performs other duties as assigned.