Institutional Review Board; IRB) Subject Matter Expert

Reports To:

Institutional Review Board Chair

Position Type:
Adjunct / Remote US-Based Schedule: 8 - 10 hours / week Bay Path University seeks an individual with college Institutional Review Board experience to support the IRB Chair in managing administrative operations, policy development, and educational outreach for human subjects research across undergraduate, graduate, and doctoral programs. This individual will serve as a key operational partner to the IRB Chair, assisting in researching and drafting university-wide IRB policies, building streamlined administrative systems, designing guidance materials and Canvas training modules, and providing direct pre-review consultation to program directors, professors, and student principal investigators (PIs).

• Assist the chair with administrative workflows and tracking systems for application intake, review routing, determination letters, and ongoing protocol monitoring.
• Assist with feedback loops and tracking mechanisms to monitor review timelines, common protocol deficiencies, and applicant resubmission patterns.

• Update and maintain user-friendly guidance documents, submission checklists, application templates, and sample consent/assent forms for student and faculty PIs.
• Design and build online educational modules and video tutorials (within Canvas) to train faculty advisors and graduate/doctoral students on developing compliant IRB applications and navigating human subjects protections.
• Organize and lead periodic virtual drop-in sessions or workshops on IRB procedures, child assent, vulnerable populations, and protocol development.

• Act as a primary liaison between the IRB and university researchers (faculty and students).
• Conduct preliminary administrative reviews of incoming IRB applications to verify completeness, identify missing documentation (e.g., CITI/ethics certificates, site permissions, consent forms), and provide constructive initial feedback prior to formal board review.
• Assist applicants in interpreting review feedback, addressing board revisions, and navigating protocol modifications.

• Assist the IRB Chair in preparing meeting agendas, distribution of protocol assignments, and drafting formal approval, modification, or determination letters.
• Maintain official, audit-ready IRB documentation, protocol files, exemptions, and compliance archives in accordance with federal retention regulations.

• Assist with researching federal guidelines (45 CFR 46 / OHRP regulations) and higher education best practices for the drafting and updating of University IRB policies and Standard Operating Procedures (SOPs).
• Develop tailored regulatory pathways, criteria, and decision trees for specialized academic programs (e.g., Applied Behavior Analysis, Nursing, Education, Health Sciences), including Quality Improvement (QI) vs. Human Subjects Research (HSR) determination frameworks.

• Education:
  
  Bachelor’s degree, and Master’s degree in Higher Education Administration, Public Health, Psychology, Nursing, Applied Behavior Analysis, Occupational Therapy, or a related research discipline preferred.
• Experience:
  
  2 years of direct experience in higher education administration, IRB operations, human subjects research compliance, or serving as an active IRB committee member/coordinator preferred.
• Regulatory Knowledge:
  Working knowledge of federal human subjects research regulations (45 CFR 46, Subparts A–D), OHRP guidance, HIPAA/FERPA standards, and the distinction between Quality Improvement (QI) and research preferred.

• Certified IRB Professional (CIP) designation or…