Research Compliance Consultant
Indiana University

Bloomington, Indiana

Posted in Education and Training


Job Info


Department

EPIDEMIOLOGY AND BIOSTATISTICS (BL-EBIO-IUBLA)

Department Information

The Department of Epidemiology and Biostatistics (EBIO) is seeking to hire a Research Compliance Consultant for supporting a wide range of research activities related to data coordination efforts, single and multisite observational cohorts and clinical trials, and other research studies. The EBIO Department has an active research agenda which generated over $2.2 million in funding in 2021 and seeks to expand both funding and collaborative partnerships.

Located on the flagship campus of the Indiana University system, SPH-B has more than 2,270 enrolled undergraduate and 360 graduate students, 200 faculty, and 78 staff in 5 departments (Applied Health Science, Environmental and Occupational Health, Epidemiology and Biostatistics, Health & Wellness Design, and Kinesiology). We are in a period of profound growth, as we have hired more than 30 new tenure-track faculty in the last 3 years. Indiana University is a member of the prestigious Association of American Universities (AAU). The city of Bloomington offers the feel of a college town with the amenities of a large city. From off-Broadway plays and musicals and the LOTUS World Festival of Music to quick access to 250,000 acres of public recreation lands and a reasonable cost of living, Bloomington offers much to all. As SPH-B continues its rapid research expansion, there has not been a more exciting time to join the school.

Job Summary

Department-Specific Responsibilities

  • Responsible for maintaining day-to-day operations of studies, including communication with site PIs, clinical coordinators, and outside organizations (e.g. NIH institutes and associated data and sample repositories).
  • Drafts and completes approvals for IRBs, data use agreements (DUAs) and other associated agreements and research oversight processes.
  • Works closely with the Department Chair, the Biostatistics Consulting Center (see https://biostats.indiana.edu ), external funding organizations and industry partners, and other members of the EBIO Department to fulfill these and other duties as assigned for overseeing day-to-day operations; also including but not limited to scheduling, setting meeting agendas, and tracking project milestones and progress.
  • May also work with other departments within and outside the School of Public Health-Bloomington as needed.
General Responsibilities
  • 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.

Qualifications

EDUCATION

Required
  • Bachelor's degree (preferably in a related field).
WORK EXPERIENCE

Required
  • 2 years of experience of research administration, research compliance, or related experience.
Combinations of related education and experience may be considered.

LICENSES AND CERTIFICATES

Preferred
  • Certification for Institutional Review Board Professionals (CIP) upon date of hire.
SKILLS

Required
  • Proficient 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.
  • Demonstrated knowledge of research regulations.

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.

Job Classification

Career Level: Career

FLSA: Exempt

Job Function: Research

Job Family: Research Compliance

Click here to learn more about Indiana University's Job Framework.

Posting Disclaimer

Due to the COVID-19 pandemic, there may be differences in the working conditions as advertised in our standard job postings (e.g., the ability to travel from one campus to another, etc.). If you are invited for an interview, please discuss your questions or concerns regarding the working conditions at that time.

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.

New employees will be provided with information regarding Indiana University's COVID-19 vaccine policy, which includes the opportunity to request an exemption. To learn more, view our COVID-19 vaccine information page.

Equal Employment Opportunity

Indiana 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 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.

Contact Us

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Telephone: 812-856-1234



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