The IRB Assistant Director will support the Director of the IRB in ensuring that all research activities involving human subjects comply with federal regulations, state laws, institutional policies, and ethical guidelines. The Assistant Director will provide leadership in overseeing the daily operations of the IRB office, assist in protocol reviews, and maintain high standards of regulatory compliance to protect research participants.
Key Responsibilities
- Regulatory Compliance: Ensure that research involving human subjects complies with all applicable laws, regulations (e.g., 45 CFR 46, 21 CFR 50, etc.), and Morehouse School of Medicine’s policies. Serve as an institutional expert on federal regulations and ethical standards related to human research protections.
- IRB Protocol Review: Assist with reviewing and evaluating IRB protocols for completeness, accuracy, and compliance with ethical and regulatory standards. Ensure that all protocols receive appropriate review in a timely manner.
- Leadership and Supervision: Provide leadership to the IRB staff and ensure smooth daily operations. Train and mentor staff on IRB policies, procedures, and regulations.
- Meeting Coordination: Assist with organizing and preparing materials for IRB meetings, including agenda development, minutes, and dissemination of decisions to investigators.
- Training and Outreach: Develop and deliver training programs for faculty, staff, and students on human subjects research compliance, IRB processes, and ethical standards. Promote awareness of the IRB’s role and research ethics across the institution.
- Communication and Liaison: Serve as a liaison between the IRB, researchers, and other institutional offices. Address inquiries regarding IRB processes, research protocols, and regulatory requirements.
- Database Management: Oversee the maintenance and operation of the electronic IRB system. Ensure accurate record-keeping and reporting of IRB activities to institutional and external stakeholders.
- Reporting: Prepare and submit reports to federal and state agencies as required. Support the Director in providing reports and updates to institutional leadership.
- Continuous Improvement: Participate in quality improvement initiatives aimed at enhancing the IRB process and ensuring the protection of research participants.
Special Instructions to Applicants
Employment in this role may be contingent upon extramural funding and successful performance and may be terminated or reduced in percentage of appointment if such funding is not secured or ceases to be available.
EEO Statement Summary
Morehouse School of Medicine is an equal opportunity/equal access/affirmative action employer fully committed to achieving a diverse workforce and complies with all Federal and Georgia State laws, regulations, and executive orders regarding non-discrimination and affirmative action. Morehouse School of Medicine does not discriminate on the basis of race, age, color, religion, national origin or ancestry, sex, gender, disability, veteran status, genetic information, sexual orientation, or gender identity or expression.