Hybrid Clinical Research Quality & Compliance Lead

Indiana University Health; Indianapolis (IN); Hybrid; USD 95,000 - 125,000; Full time

Benefits offered by this job

Job summary

Indiana University Health is seeking a Clinical Research Quality & Compliance Supervisor to lead auditing, regulatory oversight, and program quality across trials. The role is hybrid (3 days on-site, 2 remote) at Wile Hall, Indianapolis, with travel across the system.

The ideal candidate will have 5-7 years in clinical research, CCRP/CCRC within 2 years, and strong leadership, planning, and financial management skills to drive compliance and operational excellence.

Qualifications

• Bachelor's Degree is required; Master's Degree preferred.
• Requires 5-7 years of relevant experience.
• CCR P/CCRC certification within 2 years of hire.
• Experience in regulatory auditing is required.

Responsibilities

• Provide regulatory guidance to investigators, staff and committees on submissions, IRB processes, and reliance agreements.
• Mentor and train research personnel to ensure compliance with HIPAA, data safety and governance requirements.
• Review research submissions and participate in compliance discussions; advise on policy and regulatory issues.
• Coordinate with stakeholders to ensure timely submissions and defined compliance expectations.
• Support onboarding, training, SOP development, and performance management across the program.

Skills

Regulatory auditing

Leadership

Strategic planning

Financial management

Negotiation

Regulatory guidance

Education

Bachelor's degree

Master's degree preferred

CCR P/CCRC certification within 2 years

Job description

Indiana University Health is seeking a Clinical Research Quality & Compliance Supervisor to lead auditing, regulatory oversight, and program quality across trials. The role is hybrid (3 days on-site, 2 remote) at Wile Hall, Indianapolis, with travel across the system.

The ideal candidate will have 5-7 years in clinical research, CCRP/CCRC within 2 years, and strong leadership, planning, and financial management skills to drive compliance and operational excellence.