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). 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.

Job Summary

• Conducts complex and detailed risk analysis of research proposals made by IU faculty and staff researchers to evaluate whether the research is conducted in accordance with university policies, state, and federal regulations. Reports findings back to the Research Compliance Committees (IRB, The Institutional Animal Care and Use Committees (IACUCs), Institutional Biosafety Committees (IBCs), etc.).
• Develops and implements complex project plans and ensures consistency with the requirements of current and new federal, state, and local regulations and statutes as well as the compliance policies of the University.
• Manages implemented project plans including maintenance of program documentation, performance of training, monitoring and auditing.
• Collaborates with key research and operational stakeholders at IU to identify research compliance gaps, finds solutions to mitigate risks, and implements project plans.
• Continuously monitors regulatory changes and determines impact on research community.
• Serves on committees to provide advice and make recommendations to members and committee chairs, university counsel, senior administrators, faculty investigators, and other affiliated institutions as it relates to research.
• Develops and conducts training programs and conferences regarding research for committee members, faculty investigators, administrators, and staff.
• May serve as lead for major projects/initiatives; provides guidance and support to junior-level peers.

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 (preferably in related field)

Preferred

• Master's degree in related field

WORK EXPERIENCE
Required

• 5 years of experience in research compliance or regulatory experience, including high level interactions with government agencies, faculty and staff

Preferred

• Experience with regulatory environment involving research with human or animal subjects

LICENSES AND CERTIFICATES
Required

• Certification for Institutional Review Board Professionals (CIP) upon date of hire; OR
• Certified Professional in IACUC Administration (CPIA) within 2 years from date of hire

SKILLS
Required

• Demonstrated ability to maintain confidential information
• Demonstrated analytical skills
• Excellent organizational skills
• Proficient in written and verbal communication skills
• Demonstrates excellent judgment and decision-making skills
• Experience in a regulated environment
• Excellent collaboration and team building skills
• Maintains composure under pressure
• Demonstrated knowledge of research regulations
• Ability to work within tight time frames and meet strict deadlines
• Demonstrated problem solving skills
• Strong verbal communication and listening skills
• Ability to lead/manage others

Working Conditions / Demands

This role requires the ability to effectively communicate and to operate a computer and other standard office productivity equipment. The position involves sedentary work as well as periods of time moving around an office environment and the campus. The person in this role must be able to perform the essential functions with or without an accommodation.

Work Location

Indianapolis, Indiana

Advertised Salary

$55,000 - $72,000 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.