Job Description

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).
• 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.

• Indiana University Health has nearly 40,000 team members, including more than 3,600 physicians and 1,200 advanced practice providers, and we’re home to the largest nursing network in Indiana with more than 9,000 nursing team members at over 800 sites of care.
• IU Health is ranked No. 1 in Indiana by U.S. News & World Report, Riley Children's Health is ranked among the top children's hospitals in the country by U.S. News & World Report.
• A unique partnership with the Indiana University School of Medicine – one of the nation’s largest medical schools – gives patients access to groundbreaking research and innovative treatments, and it offers team members access to the latest science and the very best training – advancing healthcare for all.
• With 15 hospitals, including seven with Magnet designation and eight with Pathways to Excellence designation, our team members are leading the way through excellence.
• At Indiana University Health, your personal and professional growth is a top priority. You will have access to many diverse opportunities to learn and develop in meaningful ways that matter most to you, such as advanced clinical training, leadership development, promotion opportunities and cross training development.
• Indiana University Health is invested in the lives of Hoosiers, leading the transformation of healthcare to make Indiana one of the nation’s healthiest states.