Career Center

The University Director of the Human Research Protection Program manages the strategic direction and functions of the Indiana University Human Research Protection Program (HRPP) that is comprised of two units: Human Subjects Office (HSO) and Quality Improvement Office (QIO). This position reports directly to the Associate Vice President for Research Compliance.

• Directs leadership staff who provide supervision to research compliance program(s); establishes long-term business plans and long-term strategic objectives.
• Develops, implements, and maintains policies and procedures in accordance with university, state, and federal regulations.
• Provides oversight for the development, implementation, and documentation of appropriate training and education in research.
• Responsible for escalated operational issues, including human resources and/or people management situations.
• Drives innovation and excellence within research compliance area; reviews and creates policies and procedures.
• Serves as a subject matter expert in communicating with other compliance areas, researchers, sponsors, and federal and other external agencies regarding research compliance; participates on senior leadership teams to formulate strategic planning and the highest-level operational objectives for research compliance program(s).
• Establishes financial and resource strategies, annual operating budget, and monitors expenditures.
• Analyzes problems, current compliance environment, and national benchmarks to inform decision-making; determines research compliance best practices and standards and ensures the adoption and implementation by direct reporting leaders and team members.

EDUCATION

Required

• Bachelor's degree (preferably in related field). 

Preferred

• Master's degree. 

WORK EXPERIENCE

Required

• 5 years of research program administration, research compliance consulting, or related experience. 
• 3 years of management experience. 

Preferred

• 5 years of management experience
• 10 years of senior administrative experience in regulatory compliance and research with human subjects. 

LICENSES AND CERTIFICATES

Preferred

• Certified IRB Professional (CIP) certification upon date of hire. 
• Experience with administering and overseeing electronic data management systems.
• Experience conducting research involving human subjects or familiarity with social science or other research paradigms and methodologies.
• Experience or familiarity with FDA compliance initiatives including IND/IDE and auditing practices.
• Experience with KC IRB electronic system or other comparable human subjects electronic system.

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.
• Demonstrates excellent judgment and decision making skills.
• Effective conflict management skills.
• Builds and manages effective teams.
• Effective leadership skills.
• Ability to represent the company with external constituents.
• Ability to drive multiple projects to successful completion.
• Requires knowledge of applicable laws, regulations, and policies pertaining to compliance programs.

Preferred

• Demonstrated knowledge of federal regulations relevant to the conduct of research involving human participants.
• Ability to tactfully and respectfully deliver difficult or sensitive news and negotiate complex political situations.
• Ability to independently manage complex University programs. 
• Familiarity with federal guidelines for healthcare billings associated with clinical research, Medicare Coverage Analysis and Separation of Allowable Costs.
• Ability to negotiate and exert influence in a complex political environment.