Research Compliance Leader

Department

OFFICE OF CLINICAL RESEARCH (UA-CLTO-IUINA)

Job Summary

• Provides day-to-day operational management of research compliance staff and leadership for associated research compliance activities.
• Establishes short-term operational objectives.
• Develops program concepts, objectives, and deliverables; formulates program guidelines, criteria, and policies/procedures; establishes metrics to measure productivity and to recognize areas of concern; develops standard operating procedures (SOP's) for work flow processes according to regulatory guidelines.
• Identifies operational issues and/or areas of improvement and implements solutions to improve processes and/or operational efficiency.
• Analyzes, monitors, and evaluates performance of assigned staff; establishes work priorities, conducts performance reviews, and provides corrective action as needed.
• Ensures adequate staffing and effective scheduling; participates and informs employment decisions for assigned staff.
• Provides direct supervision and oversight of assigned staff and activities; impacts, and is held accountable for, the performance of team and/or assigned staff.
• Ensures and provides training to assigned staff to improve research compliance protocols; researches and identifies development opportunities for assigned staff.
• Keeps next-level leader(s) informed of trends as well as significant problems.

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)

WORK EXPERIENCE

Required

• 2 years of experience consulting and advising on research compliance

LICENSES AND CERTIFICATES

Required

• Certified IRB Professional (CIP), Certified Clinical Research Professional (CCRP), or other relevant professional certification upon date of hire

SKILLS

Required

• Proficient communication skills
• Maintains a high degree of professionalism
• Demonstrates time management and priority setting skills
• Demonstrates a high commitment to quality
• Excellent organizational skills
• Excellent collaboration and team building skills
• Effectively coaches and delivers constructive feedback
• Instills commitment to organizational goals
• Knowledge of applicable laws, regulations, and policies pertaining to compliance programs

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

This position is eligible 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 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: Operational

FLSA: Exempt

Job Function: Research

Job Family: Research Compliance

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 [email protected] or by visiting IUPD.

Contact Us

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Telephone: 812-856-1234