Senior IRB Analyst

Department

SSD Social and Behavioral Sciences Institutional Review Board

About the Department

The Social Behavioral Science (SBS) Institutional Review Board (IRB) protects the rights and welfare of human subjects involved in research activities being conducted under its authority. The SBS IRB serves all University of Chicago schools, divisions, and departments that do not fall under the jurisdiction of the Biological Science Division/UC Medicine.
The SBS IRB office also provides ethical and regulatory education presentations, research consultations to faculty, staff and students, reviews and investigates incidents of noncompliance and adverse events, and coordinates/maintains external relationships and reliance agreements between institutions.

Job Summary

The job maintains regulatory compliance programs, including the interpretation of systems to identify areas of risk and may coordinate internal audits. With a moderate level of direction, participates in compliance documentation, compliance training, and compliance committee formation.

The Senior IRB Analyst is responsible for facilitating the ethical conduct of research with human subjects by screening and reviewing human subjects research submissions around social behavioral research for completeness and adherence to IRB policy, institutional requirements, and state/federal regulations. Under administrative direction, the Senior IRB Analyst will serve as a member of the Institutional Review Board (IRB); facilitate the review and approval process by interpreting and applying relevant federal and state laws, regulations, and institutional policies and guidelines; conduct research and prepare guidance and reports on regulatory topics, precedent, and changes; instruct IRB members and researchers on the policies, regulations, and ethical principles essential to the review process; and provide training and advice to faculty, staff, and student researchers on the regulations and preparation of applications and materials. 100% remote position with potential for occasional travel for onsite staff meetings/trainings and departmental events.

Responsibilities

• Review submissions by interpreting and applying Federal and state laws, regulations, institutional policies and guidelines to protect human subjects and ensure institutional compliance in a timely manner. This includes ensuring that submissions are review-ready prior to routing to the committee and conducting non-committee reviews such as non-human subjects research determinations, exempt determinations, study personnel changes and expedited reviews determinations.

• Work collaboratively with researchers and students to ensure all reviews are completed accurately and in a timely manner.

• Provide IRB Committee support including composing agendas, ensure discussions and determinations are documented appropriately, draft meeting minutes, and other documentation of IRB Committee findings.

• Provide regulatory and ethical consultation to faculty, staff, and students at their request. Provide human subjects research education for faculty and student investigators by assisting the IRB Director with educational outreach and Human Subjects Research training, as needed.

• Support the IRB Director with efforts to continually improve operations and increase program consistency. This includes assisting with the ongoing review of policies and procedures.

• Coordinates department or clinic compliance with a moderate level of guidance.

• Plans and executes internal and external audits and activities to support regulatory agency inspections.

• The responsibilities listed are a general overview of the position and additional duties may be assigned.

• Performs other related work as needed.

Minimum Qualifications

Education:

Minimum requirements include a college or university degree in related field.

Work Experience:

Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.

Certifications:

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Preferred Qualifications

Education:

• Master’s degree preferred

Experience:

• Three or more years of relevant work experience as an IRB administrator or equivalent. 
• General knowledge of ethical principles, Federal regulations, and policies related to human subjects research.
• Experience reviewing social behavioral research.
• Certified IRB Professional (CIP) preferred OR to be obtained within 1 year of employment.

Technical Knowledge and Skills:

• Experience with online IRB protocol management software su