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 our employees by providing competitive rates and compensation, comprehensive employee benefits programs, attractive working conditions, and the chance to build and explore a career opportunity by offering professional development.
IRB Coordinator – Institutional Review Board
The IRB Coordinator I 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 an assigned expedited reviewer or the Board;
- Distribute research protocols to the 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 the 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.
- 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
- Minimum of 1 year of experience in IRB administration, clinical research, or regulatory compliance with human subjects
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