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IRB Analyst II
3 months ago
About Us:
At Cooper University Health Care, our commitment to providing extraordinary health care begins with our team. Our extraordinary professionals are continuously discovering clinical innovations and enhanced access to the most up-to-date facilities, equipment, technologies and research protocols. We have a commitment to its employees by providing competitive rates and compensation, a comprehensive employee benefits programs, attractive working conditions, and the chance to build and explore a career opportunity by offering professional development.
Discover why Cooper University Health Care is the employer of choice in South Jersey.
Short Description: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; prepare and distribute review materials, and agendas and minutes of IRB meetings to all IRB members; generate correspondence to investigators based on determinations made by and assigned expedited reviewer or the Board; 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.
Excellent written and oral communication skills.
Excellent time management skills.
Ability to work as an effective team member.
Ability to provide excellent customer service.
Familiarity with MS Office programs and MS Windows operating system required.
Familiarity with iMedRIS preferred.
Certification as an IRB Professional (CIP) preferred.
Experience Required: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.
Education Requirements:A Bachelors 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.
