Clinical Research Coordinator, Pediatrics Pulmonology

• Oversees study coordination and execution (scheduling visits, study management, protocol implementation)

PED-ALLERGY (IN-PALG-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.

This position manages the daily operations of pediatric pulmonary and allergy research studies, ensuring protocol compliance, participant safety, and data quality.

Responsibilities include

participant recruitment, informed consent, study visit coordination, data collection, regulatory documentation, and communication with investigators, sponsors, and clinical teams. This role supports the successful execution of clinical research while advancing scientific knowledge and improving care.

• Oversees study coordination and execution (scheduling visits, study management, protocol implementation)
• Conducts participant recruitment, screening, informed consent, study visits, assessments, and participant follow‑up
• Oversees specimen collection, processing, management, and shipping
• Oversees data collection, data entry, and source documentation
• Ensures regulatory compliance, protocol adherence, and institutional requirements
• Participates in communication and liaison activities with investigators, sponsors, participants, and research teams

• 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 Institutional Review Board (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 be substituted for work experience. Work experience beyond the minimum required may be substituted for education.

• Bachelor's degree in science or a health‑related field and 2 years of clinical research experience; OR
• Associate's degree in science or a health‑related field and 3 years of clinical research experience

• Society of Clinical Research Associates (SOCRA) / Association of Clinical Research Professionals (ACRP) clinical research certification upon date of hire