IRB ANALYST II

IRB Analyst II

The IRB Analyst II will coordinate and attend all IRB and Executive Committee meetings; assist research investigators and study coordinators in the processing of research proposals; review and track new protocol submissions, amendments, adverse event reports, and progress reports; distribute research protocols to administration for review and signatures; notify investigators about impending study expiration; manage and maintain the online electronic system and study files (online and/or paper) that document protocol activity; provide guidance and consultation to IRB members and investigators regarding implementation of federal regulations, state law, and Cooper IRB policies and procedures; and assist the IRB Manager and the IRB Chairs with special assignments.

The IRB Analyst II will independently review submissions to determine Not Human Subjects Research (NHSR) status or eligibility for Exempt review in accordance with federal regulations and institutional policies. Conduct pre-reviews of expedited studies to ensure completeness, assess risk level. Identify required revisions, provide clear guidance to investigators, and ensure accurate documentation and timely processing within the IRB system.

The IRB Analyst II will conduct limited local context review of studies ceded to external IRBs, as needed. Assist with tracking and maintaining reliance agreements and related records in coordination with the IRB Reliance Manager. Support review of external IRB studies, including pre-reviewing continuing reviews and amendments, to ensure institutional requirements are met and documentation is complete.

Knowledge of the Common Rule (45 CFR 46), FDA regulations, ICH Good Clinical Practice Guidelines, and other relevant requirements and guidelines related to the ethical study of human research subjects.

A bachelor's degree in an appropriate field or an equivalent combination of education and experience. Minimum of 2 years of experience in IRB administration, clinical research, or regulatory compliance with human subjects.

USD $31.00

USD $53.00