Clinical Research Coordinator, Pediatric Endocrinology

Department Information

The Division of Pediatric Endocrinology and Diabetology in the Department of Pediatrics at the Indiana University (IU) School of Medicine (IUSM) promotes the health of children with endocrine disorders, advances knowledge through research and other scholarly activities, and provides high-quality clinical services, child advocacy, and medical education. The division is dedicated to biomedical education through instruction of medical, graduate, and post-doctoral level students as well as residents and fellows. All of the clinical faculty are Board-certified in pediatrics. They are also Board-eligible or Board-certified in pediatric endocrinology and diabetology.

Job Summary

This position serves as primary coordinator, executing all aspects of the clinical research coordination process. This role is responsible for recruiting and screening study participants, coordinating study procedures in compliance with the Institutional Review Board (IRB) and protocol guidelines, and ensuring smooth execution of research activities. The position manages data collection and reporting, monitors protocol compliance, oversees regulatory documentation, and supports communication across the research team.

Department-Specific Responsibilities

• Supports research operations by coordinating daily aspects of study execution.
• Acts as liaison to Principal Investigator (PI) and project stakeholders.
• Submits regulatory materials as need for assigned projects.
• Manages clinical trials start-up activities, and regulatory and site operations.
• Maintains current knowledge of regulatory and research best practices, and provides back up support as needed.

General Responsibilities

• Initiates and conducts protocol review, evaluations, study design, and risk assessments of clinical research studies. Recognizes situations requiring prompt escalation and demonstrates actions to minimize risks.
• Conducts study visit activities and coordinates screening, consenting, and scheduling of tests, exams, and/or non-medical/behavioral interventions and assessments involving study subjects.
• Facilitates and performs various study activities including site evaluation visits, study related meetings and training sessions, study initiation visits (SIV) and monitoring visits.
• Manages all follow-up activities with subjects based on protocols and oversees proper documentation at study close-out.
• 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.
• 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 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.