IRB ANALYST II

IRB ANALYST II

Cooper University Health Care - 3.4 Camden, NJ Job Details Full-time 22 hours ago Benefits Health insurance Dental insurance Vision insurance Qualifications Research ethical considerations Windows State healthcare regulations Microsoft Office ICH guidelines Research regulatory compliance IRB compliance Full Job Description 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 our employees to provide competitive rates and compensation programs. Cooper offers full and part-time employees a comprehensive benefits program, including health, dental, vision, life, disability, and retirement. We also provide attractive working conditions and opportunities for career growth through professional development. Discover why Cooper University Health Care is the employer of choice in South Jersey. Short Description

REMOTE POSITION

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. Briefly explain the job's overall objective: 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. The IRB Analyst II will conduct local context review of studies that are ceded to external IRBs. Organize, track and maintain records of all reliance agreements and the covered research activities. Provide summary reports and metrics to the Director of the HRPP and Cooper leadership upon request. Coordinate and oversee institutional responsibilities outlined in the agreements and/or dictated by federal, state or local laws and policies. This may include, but is not limited to, verifying training of the research team, reviewing consent forms for local context, reviewing financial disclosures for conflicts of interest, ensuring local ancillary reviews are completed, reviewing reports of unanticipated problems or suspected non-compliance. 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 Sitero MentoriMedRIS preferred. Familiarity with NJ law and regulations related to human research highly 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 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. Full Time Day