Research Compliance Consultant

Company: Indiana University
Location: South Bend
Posted on: August 30, 2024

Job Description:

DepartmentRESEARCH COMPLIANCE (UA-RCIN-IUINA)Department InformationThe mission of the Office of Research Compliance (ORC) is to ensure that research conducted by IU and affiliated researchers is not only in compliance with all applicable regulatory, statutory, and organizational requirements, but also meets the standards of best practices while minimizing impediments to research and burdens on the research community.The IU Human Subjects Office (HSO) is the administrative office that supports the Indiana University Institutional Review Boards (IRBs), which are responsible for the review and approval of all research involving human subjects conducted at IU and its affiliated institutions. The HSO administers the human research protection program (HRPP) at IU. IU's HRPP, which included the regional campuses effective July 1, 2015, is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).Job Summary

• Performs a final review and screening of research applications to ensure studies meet regulatory approval for criteria; screens revised applications and resubmissions, reviews changes, and approves/raises concerns; attends compliance regulatory meetings (such as IRB) to advise on regulatory and policy issues, and analyze board discussion for action taken on research projects.
• Consults with and advises faculty and investigators/researchers on the application submission process; interprets and advises on applicable policies, procedures, guidelines, federal regulations, and other compliance-related requirements.
• Acts as a liaison between committees and chairpersons (IRB), investigators, and various university stakeholders (such as Office of Research Administration (ORA), Office of Research Compliance (ORC) including the Radiation Safety Office, Conflict of Interest Committee, etc. as necessary).
• Ensures researchers/investigators are aware of time limits and deadlines.
• May serve as a mentor, advisor, educator, and/or resource to other research compliance teams and/or staff.
• Provides necessary education and training to both internal and external researchers, research staff, and other research compliance staff, as needed.
• Makes recommendations for streamlining review process such as the revision of applications and consent forms, investigator notification, prior categorization and assignment of application submitted, etc; performs quality checks and ensures the necessary corrective and preventive actions are completed.
• May serve as project lead on assigned special projects.QualificationsCombinations 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. EDUCATIONRequired
  • Bachelor's degree preferably in related fieldWORK EXPERIENCERequired
    • 2 years of experience of research administration, research compliance, or related experienceLICENSES AND CERTIFICATESPreferred
      • Certification for Institutional Review Board Professionals (CIP) upon date of hireSKILLSRequired
        • 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
        • Demonstrates knowledge of research regulationsPreferred
          • Ability to understand, interpret, and apply complex federal, state, university, and accreditation regulations pertaining to research involving human subjectsWorking Conditions / DemandsThis 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 LocationIndianapolis, Indiana and Bloomington, IndianaThis position is eligible for remote work or to work a hybrid schedule (mix between remote and in-person work), subject to change in the future based on university policy and business needs. Benefits OverviewFor full-time staff employees, Indiana University offers a wide array of benefits including:
            • Multiple plan options for medical insurance
            • Dental insurance
            • Health Savings Account with generous IU contribution
            • Life insurance, LTD, and AD&D options
            • Base retirement plan contribution from IU, subject to vesting
            • Additional supplemental retirement plan options
            • Tuition benefit for IU classes
            • 10 paid holidays per year
            • Generous Paid Time Off
            • Paid Parental Leave
            • Employee Assistance Program (EAP)Learn more about our benefits by reviewing our online Benefits Brochure.Job ClassificationCareer Level: CareerFLSA: ExemptJob Function: ResearchJob Family: Research ComplianceClick here to learn more about Indiana University's Job Framework.Posting DisclaimerThis 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 OpportunityIndiana University is an equal employment and affirmative action employer and a provider of ADA services. All qualified applicants will receive consideration for employment based on individual qualifications. Indiana University prohibits discrimination based on age, ethnicity, color, race, religion, sex, sexual orientation, gender identity or expression, genetic information, marital status, national origin, disability status or protected veteran status. Indiana University does not discriminate on the basis of sex in its educational programs and activities, including employment and admission, as required by Title IX. Questions or complaints regarding Title IX may be referred to the U.S. Department of Education Office for Civil Rights or the university Title IX Coordinator. See Indiana University's Notice of Non-Discrimination here which includes contact information.Campus Safety and SecurityThe 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.Contact UsRequest SupportTelephone: 812-856-1234

Keywords: Indiana University, South Bend , Research Compliance Consultant, Professions , South Bend, Indiana