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.
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.
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.
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.
USD $29.00
USD $50.00
Cooper University Health Care is the leading academic health system in South Jersey and provides access to primary, specialty, tertiary, and urgent care, all within one complete health system. Cooper has nearly 14,000 team members including 1,600 nurses, more than 1,000 employed physicians representing 95 specialties and subspecialties, and more than 600 advanced practice professionals. Hospitals throughout the region send their most complex and critically ill and injured to Cooper for treatment by our highly skilled experts.
Ranked year after year by U.S. News & World Report as one of the top health systems in the Philadelphia Metro area, Cooper is consistently recognized for its quality, safety, and exceptional patient care.
Cooper has three hospitals: South Jersey’s only Level I trauma center, Cooper University Hospital in Camden, which is the busiest trauma center in the Philadelphia region; Cooper University Hospital Cape Regional in Cape May Court House, and Children’s Regional Hospital at Cooper, which is the only Level II pediatric trauma center in the Delaware Valley. Cooper is also home to a leading cancer center (MD Anderson Cancer Center at Cooper), six urgent care centers, and more than 130 outpatient offices from the Delaware River to the Jersey Shore, including large regional hubs in Camden, Cherry Hill, Moorestown, Voorhees, Willingboro, and Sewell.
Cooper University Health Care is affiliated with – and its physicians make up the faculty of – Cooper Medical School of Rowan University, which is located on the Cooper Health Sciences Campus in Camden, New Jersey. Cooper has a long history in the City of Camden and is playing a leading role in its revitalization.
