Job DescriptionIndiana 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.
