Institutional Review Board (IRB) Subject Matter Expert

Reports To: Institutional Review Board Chair Position Type: Adjunct / Remote US-Based Schedule: 8 - 10 hours / w eek 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). Key Responsibilities 1. Systems, Intake & Workflow Management 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. 2. Training, Instructional Design & Outreach 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. 3. Applicant Consultation & Communication 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. 4. Board Support & Record Keeping 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. 5. Policy Research & Protocol Development 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. Compensation: $500 - $1,200 per credit. Adjunct faculty pay rates vary, depending on the academic discipline and the course's credit load and level. Preferred Qualifications & Competencies 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 eligibility is a plus. Instructional Design & Technology: Familiarity with Canvas (or similar Learning Management Systems), video creation tools, and online form/workflow management tools preferred. Communication: Exceptional technical writing, policy drafting, and interpersonal skills with a supportive, educational coaching approach toward student researchers. Methodological Familiarity: Understanding of varied research methodologies, such as qualitative, quantitative, single-case experimental designs, and educational/clinical program evaluations preferred. Ability to adhere to University's policies and procedures. Ability to handle confidential information with discretion and within FERPA and HIPAA guidelines. All new employees must complete the FERPA, Anti-Harassment, and any other required online trainings within 15 days of employement. General knowledge of the University's mission, purpose, and goals and the role this position plays in achieving those goals.