IRB Analyst

RESEARCH COMPLIANCE (UA-RCIN-IUINA)

Indiana University (IU) Human Research Protection Program (HRPP), within the Office for Research Compliance, is responsible for ensuring that the human subject research conducted at IU campuses and affiliated hospitals is done in an ethically compliant manner. The day-to-day operations of the IU Institutional Review Boards (IRBs) are administered and supported by the IU Human Subjects Office (HSO). Like the IRB, HSO staff have varying backgrounds.

Some HSO staff conduct preliminary review of all research submitted to the IRB to ensure that it is in an acceptable form for the IRB to review. HSO staff provide guidance to researchers as to whether an activity requires IRB review; however, HSO staff may consult with IRB members with any questions. The Quality Improvement Office, also a unit of the HRPP, conduct not-for-cause and for-cause audits of human subjects research.

Additionally, HRPP staff are available to answer questions, and offer educational and training opportunities to researchers as it relates to human subjects research.

• Conduct pre-review of submissions to the designated IRB of new protocols, continuing reviews, and modifications to approved studies.
• Provide risk management for IRB submissions. Review of correspondence and conducting quality improvement initiatives.
• Collaborate with other IRB officers of administration and staff to ensure uniformity of review and compliance with IRB standard operating procedures and applicable federal and state regulations.
• Serve on relevant IRB administrative committees, such as the Policy Committee, or the Education and Training Committee.
• Maintain up-to-date knowledge of state and federal regulations and policies, guidelines and ethical codes related to the protection of human subjects in research.
• May supervise lower IRB Analysts.

• Bachelor's degree in a science or health related field

• 5 years of experience preferably in IRB administration.

• Certified IRB Professional (CIP), Certified Clinical Research Professional (CCRP), or any other relevant clinical research professional certification Upon Date of Hire

• Proficient communication skills
• Maintains a high degree of professionalism
• Demonstrates time management and priority setting skills
• Demonstrates a high commitment to quality
• Possesses flexibility to work in a fast paced, dynamic environment
• Seeks to acquire knowledge in area of specialty
• Highly thorough and dependable
• Demonstrates a high level of accuracy, even under pressure
• Possesses a high degree of initiative
• Ability to influence internal and/or external constituents

The role regularly requires the ability to effectively communicate. The role frequently requires the ability to move about the work environment and to position oneself to operate laboratory equipment effectively. The role requires the ability to move objects weighing up to 25 pounds and will occasionally work near moving mechanical parts. The person in this role must be able to perform the essential functions with or without an accommodation.

Indianapolis, Indiana

• Comprehensive medical and dental insurance
• Health savings account with generous IU contributions
• Healthcare and dependent care flexible spending accounts
• Basic group life insurance paid by IU
• Voluntary supplemental life, long-term disability, critical illness, and supplemental accidental death & dismemberment insurance
• Base retirement plan with generous IU contributions, subject to vesting
• Voluntary supplemental retirement plan options
• Tuition subsidy for employees and family members taking IU courses
• 10 paid holidays plus a paid winter break each year
• Generous paid time off plans
• Paid leave for new parents and IU-sponsored volunteer events
• Employee assistance program (EAP)

Indiana University is an equal opportunity employer and provider of ADA services and prohibits discrimination in hiring. See Indiana University Notice of Non-Discrimination here which includes contact information.