IRB Analyst II
Core
Coordinates daily activities for processing research protocols and managing the Institutional Review Board (IRB) and Human Research Protection Program (HRPP) to ensure compliance with federal regulations and protect human subjects.
Role type
Senior IC IRB Analyst
Builds
Protocol review workflows, meeting agendas, and compliance documentation for human subjects research
Domain
Healthcare + Regulatory Compliance
Required skills
ICH/GCP guidelines, FDA regulations, OHRP regulations, HIPAA Privacy Rule, medical and clinical terminology, research methodology and design
Preferred skills
Master's degree
Technologies
Microsoft Office, customized database software
Responsibilities
Reviews and processes exempt and expedited protocol submissions; coordinates IRB meetings and prepares minutes; facilitates review of central and external IRB submissions; assists with quality assurance audits and compliance monitoring; develops training materials for HRPP staff; serves as liaison to academic units.
Seniority
Mid-level, hands-on IC