Clinical Research Specialist, Pediatric Endocrinology​/Diabetology

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.

The IUSM Department of Pediatrics Division of Pediatric Endocrinology/Diabetology is seeking a Clinical Research Specialist who is responsible for recruiting and screening study participants, coordinating study procedures in compliance with Institutional Review Board (IRB) and protocol guidelines, and ensuring smooth execution of research activities. The Clinical Research Specialist manages data collection and reporting, monitors protocol compliance, oversees regulatory documentation, and supports communication across the research team.

• Supports research operations by coordinating daily aspects of study execution including participant recruitment, screening, and consent; conducts study visits and follow-up for studies (Trial Net Pathway to Prevention, TN-16 LIFT, Dx-T1D, Medtronic CIP
  351 starting January 2026, and BIOMARKER).
• Acts as the liaison to Principal Investigator (PI) and project stakeholders and submits regulatory materials as need for assigned projects.
• Maintains current knowledge of regulatory and clinical research best practices through ongoing education and team engagement; provides additional study support as needed.

• Assists with identifying and recruiting potential research study subjects; determines eligibility according to the IRB/protocol approved methodologies, coordinates study procedures, and monitors the progress of research studies or projects.
• Conducts study visit activities and coordinates screening, consenting, and scheduling of test, exams, and/or non-medical/behavioral interventions and assessments involving study subjects; coordinates, facilitates, and performs various study activities; manages all follow-up activities with subjects based on protocols.
• Records study data, samples, and/or results in various databases; maintains databases for subjects and subject scheduling; performs data validation checks and pursues resolutions to erroneous data; produces various reports in response to requests from PI, sub-investigators, and/or other study stakeholders.
• Monitors study team compliance with protocol and Standard Operating Procedures (SOPs); submits all regulatory paperwork required; communicates with PI and sub-investigators about concerns or recommended changes in study protocols, etc.
• Assists with developing various communications and strategies for advertising and recruitment, as well as in developing information materials for study participants.
• Stays up to date on regulatory affairs and/or clinical research best practices by attending continuing education classes, conferences, seminars, and project team meetings.
• Provides various other clinical research study or project support as needed (such as assisting with budget development, invoicing for adverse events, billing compliance and patient billing resolution).
• May provide guidance and/or support to less experience clinical research staff.

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 1 year of health-related or research experience;
  OR
• Associate's degree in an allied health profession and 3 years of health-related or research experience.

• Proficient in written and verbal communication skills.
• Maintains…