A leading provider of health care in South Jersey requiring a superior, diverse and well-trained group of clinicians, researchers, administrators and information technology specialists. Cooper University Hospital and our network of satellite offices provide the residents of South Jersey, Philadelphia and the entire Delaware Valley access to a wide array of services, which include prevention and wellness, primary and specialty physician services, hospital care, and ambulatory diagnostic and treatment services.
Our commitment to providing extraordinary health care begins with our human resources. Our professionals are continuously discovering clinical innovations and enhanced access to the most up to date facilities, equipment, technologies and research protocols. Cooper University Health Care has 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.
The IRB Coordinator 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.
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.
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.
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.