Clinical Research Coordinator, Pediatrics Health Services Research

PED-HEALTH SERVICES RESEARCH (IN-PHSR-IUINA)

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 (IU) School of Medicine (IUSM) to make Riley Children's Health Indiana's largest and most skilled pediatric system. At IUSM, our mission and core values define who we are, how we act, and what we aspire to accomplish.

• 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, wait listing, and priority listing data.
• Leads regulatory start-up and ongoing activities across five participating institutions, including institutional review board (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 onboarding, training, and mentorship of research personnel at the coordinating center and participating sites.

• Initiates and conducts protocol review, evaluations, study design, and risk assessments of clinical research studies.
• Participates in study budget negotiations and reconciles study budget accounts.
• Develops informational materials for recruitment of subjects. Monitors enrollment goals and modifies recruitment strategy as needed.
• Oversees and ensures compliance with regulations, including organizing electronic files and/or filing regulatory documents appropriately. Prepares and submits IRB documents (i.e., Informed Consent, advertisement, protocol and protocol summary). Prepares regulatory documents for sponsor.
• Identifies and selects potential subjects by reviewing existing protected health information, screening subjects, and conducting interviews. Performs subject interviews and assessments for data required by protocol(s).
• Follows up on study documentation with necessary stakeholders (healthcare providers, study participants, laboratory personnel, etc.).
• Reviews incoming subject adverse event (SAE) information, assists Principal Investigator (PI) in making submission determination of SAEs, and follows up to determine resolution of adverse events.
• Conducts study-related non-medical/behavioral assessments/interventions as well as study procedures/interventions (appropriate licensure may apply).
• Records, documents, and reports protocol deviations and trial changes to PI and sub-investigators.
• Stays up to date with knowledge of regulatory affairs and/or issues.

Combinations of related education and experience may be considered. Education beyond the minimum required may…