IRB ANALYST II

AtCooper 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.

FULLY 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 independently review submissions to determine Not Human Subjects Research (NHSR) status or eligibility for Exempt review in accordance with federal regulations and institutional policies. Conduct pre-reviews of expedited studies to ensure completeness, assess risk level. Identify required revisions, provide clear guidance to investigators, and ensure accurate documentation and timely processing within the IRB system.

The IRB Analyst II will conduct limited local context review of studies ceded to external IRBs, as needed. Assist with tracking and maintaining reliance agreements and related records in coordination with the IRB Reliance Manager. Support review of external IRB studies, including pre-reviewing continuing reviews and amendments, to ensure institutional requirements are met and documentation is complete.

Knowledge of the Common Rule (45 CFR 46), FDA regulations, ICHGood Clinical Practice Guidelines, and other relevant requirements and guidelines related to the ethical study of human research subjects.

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.

The New Jersey Pay Transparency Act requires disclosure of the pay range for this position.

A salary offer will vary based on the job role, candidate experience, qualifications, internal pay equity and market data.

Cooper University Health Care is an Equal Opportunity Employer and is committed to equal employment opportunity for all team members. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, or any other status protected by law or regulation. To request reasonable accommodation, contact talent-acquisition@cooperhealth.edu