IRB Analyst

William Paterson University•Wayne, NJ

1d•Onsite

About The Position

The IRB Analyst reports to the IRB Administrator within the Office of Sponsored Programs. The role provides regulatory support to William Paterson University’s Institutional Review Board (IRB), assessing research protocols for completeness, accuracy, and appropriate review level under applicable regulations and institutional policy. The analyst coordinates and attends convened IRB meetings, maintains Human Ethics administration roles in Cayuse, supports IRB members, and serves as a resource to the research community. The position provides guidance and assistance to investigators and study coordinators on protecting human subjects and on reviewing and processing research protocols. It also supports the IRB’s daily operations and administration, including protocol tracking, meeting preparation, correspondence, and procedural development.

Requirements

Bachelor’s degree in an appropriate field or an equivalent combination of education and experience.
At least 2 years of experience in IRB administration, clinical research, or human-subjects regulatory compliance.
Familiarity with Microsoft Office programs and the Microsoft Windows operating system.
Excellent written and oral communication skills.
Excellent time-management skills.
Ability to work effectively as a team member.
Ability to provide excellent customer service.
Ability to assist in establishing systems and procedures.

Nice To Haves

Familiarity with the Cayuse software platform or a similar grant management platform.
Familiarity with New Jersey law and regulations related to human research.
Certification as an IRB Professional (CIP).
Knowledge of the Common Rule (45 CFR 46) and other relevant requirements and guidelines for the ethical study of human research subjects.

Responsibilities

Provide administrative support for the university’s IRB review software, Cayuse, and maintain study files documenting protocol activity.
Provide regulatory support to the IRB and manage its daily operations.
Guide and consult with IRB members and investigators about federal regulations, state law, and university IRB policies and procedures.
Assist faculty, staff, students, and study coordinators with processing IRB proposals.
Review and track new protocol submissions, amendments, adverse event reports, and progress reports.
Coordinate, schedule, and attend IRB meetings; prepare agendas and accurate minutes; and distribute meeting materials to IRB members.
Prepare correspondence to investigators based on reviewer or Board determinations, including notices of impending study expiration.
Conduct comprehensive pre-review analyses of submissions for completeness and communicate identified deficiencies to investigators.
Conduct local context reviews, including verifying research team training, reviewing consent forms for local context and financial disclosures for conflicts of interest, and escalating unanticipated problems or suspected non-compliance to the IRB Administrator.
Maintain education and training to keep job-related knowledge current.
Assist the IRB Administrator with identifying and developing updated human-subject protection procedures and guidelines, process improvement initiatives, and special projects.
Perform other duties appropriate to the position.