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William Paterson University

Public university in Wayne, NJ

IRB Analyst

Regulatory Compliance & EthicsConfirmed live in the last 24 hours
Part-timeWayne, NJ, USA$25 /hr

About the Job

Requirements

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

Responsibilities

  • Provide administrative support for the university's IRB review systems, including Cayuse, and maintain study files documenting protocol activity.
  • Provide regulatory support to the IRB and manage its daily operations.
  • Provide guidance and consultation to IRB members and investigators on federal regulations, state law, and university IRB policies and procedures.
  • Assist faculty, staff, students, and study coordinators with processing proposals for the university IRB.
  • Review and track new protocol submissions, amendments, adverse event reports, and progress reports.
  • Coordinate, schedule, and attend IRB meetings; prepare meeting agendas and accurate minutes; and distribute review materials, agendas, and minutes to IRB members.
  • Generate correspondence to investigators based on determinations by an assigned reviewer or the Board, including notices about impending study expiration.
  • Conduct comprehensive pre-review analysis of submission documents 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 current education and training related to job duties.
  • Assist the IRB administrator in identifying areas for development and updating human-subject protection procedures, guidelines, process-improvement initiatives, and special projects.

Desired Qualifications

  • Familiarity with Cayuse or a similar grant management platform.
  • Familiarity with New Jersey laws 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 related to the ethical study of human research subjects.

About the Company

William Paterson University

Public university in Wayne, NJ

William Paterson University is a public university in Wayne, New Jersey. It provides undergraduate and graduate education across arts, sciences, business, education, health, and professional fields.

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