Clinical Research Quality and Compliance Supervisor

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

Overview

Our leaders shape strategic initiatives, develop passionate teams, and work to improve health outcomes. They advance our mission and exemplify excellence, compassion, teamwork and purpose in all that they do.

Indiana University Health is seeking individuals who embody these values to join our Clinical Research Management team in the role of Clinical Research Quality and Compliance Supervisor. This position is a hybrid role with 3 days on site and 2 days remote, the position will be located at Wile Hall in Indianapolis, IN however travel throughout our entire system is expected.

Join a growing clinical research program where you'll lead quality and compliance efforts that support innovative research across the state. As the Supervisor of Clinical Research Quality & Compliance, you will oversee a team responsible for auditing research activities, ensuring regulatory compliance, maintaining quality standards, and supporting the successful start-up and oversight of clinical studies. You'll partner closely with investigators, research teams, providers, and external sponsors to drive consistency, continuous improvement, and operational excellence throughout the research lifecycle.

This role leads compliance activities for IU Health Enterprise Clinical Research Operations, supporting compliant research practices across clinical trials and related research activities.

Minimum Candidate Qualifications

Required

• Bachelor's Degree is required. Master's Degree is preferred.
• Requires 5-7 years of relevant experience.
• Healthcare industry experience is a plus.
• Requires a blend of management skills with technical expertise proven by superior planning, decision-making, negotiation, leadership and financial management skills/knowledge with a focus to adding value to the bottom line of the business.
• Requires Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) within 2 years of hire
• Must have experience in regulatory auditing.

Preferred

• Leadership or supervisory experience.
• Experience developing or implementing policies and standard work procedures.
• Experience supporting large-scale or multi-site research studies.
• Strong clinical research background.
• Experience within clinical research quality, compliance, regulatory affairs, or research operations.
• Working knowledge of clinical trial regulations, research governance, and compliance requirements.
• Experience conducting audits, reviews, or quality monitoring activities.
• Prior experience partnering with investigators, research coordinators, and clinical teams.

Core Competencies

• Provides regulatory guidance to investigators, research staff, and committees on submissions, protocols, IRB processes, and reliance agreements.
• Mentors and trains research personnel to support compliance with institutional, legal, data safety, HIPAA, and coverage analysis requirements.
• Reviews research submissions, participates in compliance discussions, and advises on policy and regulatory issues.
• Coordinates with stakeholders to ensure submission requirements, timelines, and compliance expectations are understood and met.
• Facilitates statewide collaboration and supports onboarding, training resources, SOP development, staff objectives, and performance management.

Indiana University Health is unlike any other healthcare system and we're looking for team members who share the things that matter most to us. IU Health leaders play a crucial role in advancing the mission of our organization and inspiring teams to make a meaningful difference in the lives of patients. As one of Indiana’s largest employers and the most comprehensive medical system in the state, our vision is to lead the transformation of healthcare through quality, innovation and education, and make Indiana one of the nation’s healthiest states.

IU Health is the largest health system in Indiana with nearly 40,000 team members, 15 hospitals and $8.64 billion in operating revenue. The system’s programs in cancer, cardiovascular, neuroscience, orthopedics, pediatrics and transplants have received national recognition for quality patient care. IU Health, in partnership with the Indiana University School of Medicine, bring together highly skilled physicians, researchers, and educators into close collaboration to provide world-class care for children and adults and improve the health of patients and communities across Indiana.

Indiana University Health is dedicated to a fair hiring process and is committed to equal opportunity and nondiscrimination for all individuals, regardless of age, color, disability, ethnicity, marital status, national origin, race, religion, gender identity, expression, sexual orientation, or veteran status.

We are an equal opportunity employer. IU Health does not discriminate on the basis of race, color, religion, sex, sexual orientation, age, disability, genetic information, veteran status, national origin, gender identity and/or expression, marital status or any other characteristic protected by federal, state or local law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.