Clinical Research Coordinator, Pediatrics Health Services Research

About the role

The Department of Pediatrics employs nearly 1,000 faculty and staff who work alongside employees of Riley Hospital for Children and students of Indiana University School of Medicine to make Riley Children's Health Indiana's largest and most skilled pediatric system. At IU School of Medicine, our mission and core values define who we are, how we act, and what we aspire to accomplish.

Location: Indianapolis, Indiana.

Responsibilities

• Leads day-to-day operations of a complex, multisite pediatric kidney transplant research study across five high-volume pediatric transplant centers.
• Serves as the primary operational contact for participating sites and coordinates activities among investigators, research personnel, regulatory offices, data teams, and Dr. Laster.
• Coordinates retrospective and prospective data collection for pediatric patients with end-stage kidney disease (ESKD), including kidney transplant referral, evaluation, waitlisting, and priority listing data.
• Leads regulatory start-up and ongoing activities across five participating institutions, including IRB submissions, amendments, continuing reviews, reliance processes, and study closeout.
• Coordinates data use agreements and other institutional agreements with university offices and participating sites.
• Maintains regulatory documentation, study records, data dictionaries, and tracking systems.
• Exercises independent judgment in monitoring study compliance, documentation, and data quality.
• Identifies and resolves protocol and operational issues in collaboration with investigators, sponsors, and regulatory personnel.
• Reviews adverse event documentation, assists with reportability determinations, and tracks corrective and preventive actions.
• Evaluates protocols for operational feasibility, identifies implementation challenges, and develops strategies to support successful study execution.
• Contributes to protocol development, study planning, workflow design, and quality improvement initiatives.
• Supports on