IRB Analyst: Regulatory & Human Subjects Expert

William Paterson University; Wayne (NJ); On-site; USD 28,000 - 40,000; Full time

Job summary

William Paterson University in Wayne, NJ seeks an IRB Analyst to support the University’s Institutional Review Board. You will coordinate regulatory reviews, maintain Cayuse administration, and guide investigators on federal regulations and institutional policies.

Strong communication, organizational, and teamwork skills are essential for timely review and compliance. This role offers the chance to contribute to human subjects protections, participate in IRB meetings, and support research

Qualifications

• Bachelor’s degree in an appropriate field or an equivalent combination of education and experience.
• Minimum 2 years of experience in IRB administration, clinical research, or regulatory compliance with human subjects.
• Familiarity with MS Office programs and MS Windows operating system.

Responsibilities

• Provide administrative support to the software IRB review systems in place at WP (Cayuse) including study files (online and/or paper) that document protocol activity.
• Independently performs critical regulatory support to WP IRB and manages daily operations of the IRB.
• Provide guidance and consultation to IRB members and investigators regarding implementation of federal regulations, state law, and WP IRB policies and procedures.
• Assist faculty, staff, students and study coordinators in the processing of proposals for the WP IRB.
• Review and track new protocol submissions, amendments, adverse event reports, and progress reports.
• Coordinate, schedule, and attend IRB meetings, including preparation of meeting agendas and accurate meeting minutes. Prepare and distribute review materials, agendas and minutes of IRB meetings to all IRB members.
• Generate correspondence to investigators based on determinations made by an assigned reviewer or the Board, including notify investigators about impending study expiration.
• Performs comprehensive pre-review analysis of submission documents for completeness and communicates all identified deficiencies to investigators.
• Conduct local context review of studies that 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, and escalating to the IRB administrator unanticipated problems or suspected non-compliance.
• Maintain education and training to ensure current and up to date knowledge for all job-related aspects.
• Assist the IRB Administrator in identifying areas for development and updating of IRB human subject protection procedures, guidelines, process improvement initiatives, and other special projects.
• Other duties as appropriate to the position.

Skills

Excellent written and oral comms

Time management

Customer service

Teamwork

Education

Bachelor’s degree in an appropriate field

Equivalent combination of education and experience

Tools

Cayuse

MS Office

Job description

William Paterson University in Wayne, NJ seeks an IRB Analyst to support the University’s Institutional Review Board. You will coordinate regulatory reviews, maintain Cayuse administration, and guide investigators on federal regulations and institutional policies.

Strong communication, organizational, and teamwork skills are essential for timely review and compliance. This role offers the chance to contribute to human subjects protections, participate in IRB meetings, and support research