Clinical Research Quality and Compliance Supervisor

IU Health•Indianapolis, IN

9d•Hybrid

About The Position

Indiana University Health is seeking individuals who embody excellence, compassion, teamwork, and purpose to join their 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, located at Wile Hall in Indianapolis, IN, with travel throughout the system expected. The role leads compliance activities for IU Health Enterprise Clinical Research Operations, supporting compliant research practices across clinical trials and related research activities. The Supervisor of Clinical Research Quality & Compliance 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. This role partners closely with investigators, research teams, providers, and external sponsors to drive consistency, continuous improvement, and operational excellence throughout the research lifecycle.

Requirements

Bachelor's Degree is required.
Requires 5-7 years of relevant experience.
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.

Nice To Haves

Master's Degree is preferred.
Healthcare industry experience is a plus.
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.

Responsibilities

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.