Clinical Research Quality and Compliance Supervisor

IU Health; Indianapolis (IN); Hybrid; USD 110,000 - 140,000; Full time

Job summary

Indiana University Health is seeking a Clinical Research Quality & Compliance Supervisor to lead the program's quality and regulatory efforts. You will oversee audits, ensure compliance across studies, and support start-up activities with a focus on operational excellence and continued improvement.

The role requires mentoring teams, partnering with investigators and sponsors, and traveling within the system. This hybrid position is based in Indianapolis, IN.

Qualifications

• Bachelor's Degree is required; Master's Degree preferred.
• 5-7 years of relevant experience.
• Healthcare industry experience is a plus.
• Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) within 2 years of hire.
• Experience in regulatory auditing.

Responsibilities

• Lead quality and compliance efforts across the clinical research program.
• Audit research activities and ensure regulatory compliance.
• Support start-up and oversight of clinical studies.
• Partner with investigators, research teams, providers and sponsors to drive consistency and improvement.
• Mentor research personnel on institutional, legal, HIPAA and governance requirements.

Skills

Leadership

Regulatory auditing

Project management

Communication

Financial management

Education

Bachelor's Degree

Master's Degree preferred

Tools

CCRP

CCRC

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 leadscompliance 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 isunlike 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.