Description

The 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 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.

Job Summary

• Conducts pre-review of submissions to the designated IRB of new protocols, continuing reviews, and modifications to approved studies
• Provides risk management for IRB submissions. Review of correspondence and conducting quality improvement initiatives
• Collaborates 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
• Serves on relevant IRB administrative committees, such as the Policy Committee, or the Education and Training Committee
• Maintains 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

Qualifications

Combinations of related education and experience may be considered. Education beyond the minimum required may be substituted for work experience. Work experience beyond the minimum required may be substituted for education.

EDUCATION
Required

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

WORK EXPERIENCE
Required

• 5 years of experience preferably in IRB administration

LICENSES AND CERTIFICATES
Required

• Certified IRB Professional (CIP) upon date of hire
• Certified Clinical Research Professional (CCRP) upon date of hire
• Any other relevant clinical research professional certification upon date of hire

SKILLS
Required

• Proficient written and verbal communication skills
• Maintains a high degree of professionalism
• Demonstrated 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

Working Conditions / Demands

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.

Work Location

Indianapolis, Indiana

Advertised Salary

$64,646.40 - $72,000.00 annually

Benefits Overview

For full-time staff employees, Indiana University offers a wide array of benefits including:

• 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)

Learn more about our benefits by reviewing the IU Benefit Programs Brochure .

Job Classification

Career Level: Advanced
FLSA: Exempt
Job Function: Research
Job Family: Research Compliance
Click here to learn more about Indiana University's Job Framework.

Posting Disclaimer

This posting is scheduled to close at 11:59 pm EST on the advertised Close Date. This posting may be closed at any time at the discretion of the University, but will remain open for a minimum of 5 business days. To guarantee full consideration, please submit your application within 5 business days of the Posted Date.
If you wish to include a cover letter, you may include it with your resume when uploading attachments.

Equal Employment Opportunity

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 .

Campus Safety and Security

The Annual Security and Fire Safety Report, containing policy statements, crime and fire statistics for all Indiana University campuses, is available online . You may also request a physical copy by emailing IU Public Safety at iups@iu.edu or by visiting IUPD.