IRB ANALYST II

Cooper University Hospital•Camden, NJ

2d•$29 - $50

About The 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. 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.

Requirements

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.
Familiarity with MS Office programs and MS Windows operating system required.
Minimum of 2 years of experience in IRB administration, clinical research, or regulatory compliance with human subjects.

Nice To Haves

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 Sitero MentoriMedRIS preferred.
Familiarity with NJ law and regulations related to human research highly preferred.
Certification as an IRB Professional (CIP) preferred.

Responsibilities

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 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
Assist the IRB Manager and the IRB Chairs with special assignments
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
Verify training of the research team
Review consent forms for local context
Review financial disclosures for conflicts of interest
Ensure local ancillary reviews are completed
Review reports of unanticipated problems or suspected non-compliance