Description

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

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.
Department-Specific Responsibilities

• Supports research operations by coordinating daily aspects of study execution including participant recruitment, screening, and consent; conducts study visits and follow-up for
  studies (TrialNet Pathway to Prevention, TN-16 LIFT, Dx-T1D, Medtronic CIP351 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.

General Responsibilities

• 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.

Qualifications

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.

EDUCATION / WORK EXPERIENCE
Required

• 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.

SKILLS
Required

• Proficient in written and verbal communication skills.
• Maintains a high degree of professionalism.
• Demonstrated time management and priority setting skills.
• Demonstrates a high commitment to quality.
• Possesses flexibility to work in a fast paced, dynamic environment.
• Highly thorough and dependable.
• Possesses a high degree of initiative.
• Ability to build strong customer relationships.

Working Conditions / Demands

The role regularly requires the ability to effectively communicate. The role frequently requires the ability to move about the work environment and to position oneself to operate laboratory equipment effectively. The role requires the ability to move objects weighing up to 25 pounds and will occasionally work near moving mechanical parts. The person in this role must be able to perform the essential functions with or without an accommodation.

Additional Information

This position is not eligible for visa sponsorship.

Work Location

Indianapolis, Indiana

Advertised Salary

$48,000 - $53,000 annually, based on a combination of experience, skill level, education, and training.

Benefits Overview

For full-time staff employees, Indiana University offers a wide array of benefits including:

• Comprehensive medical and dental insurance
• Health savings account with generous IU contributions
• Healthcare and dependent care flexible spending accounts
• Basic group life insurance paid by IU
• Voluntary supplemental life, long-term disability, critical illness, and supplemental accidental death & dismemberment insurance
• Base retirement plan with generous IU contributions, subject to vesting
• Voluntary supplemental retirement plan options
• Tuition subsidy for employees and family members taking IU courses
• 10 paid holidays plus a paid winter break each year
• Generous paid time off plans
• Paid leave for new parents and IU-sponsored volunteer events
• Employee assistance program (EAP)

Learn more about our benefits by reviewing the IU Benefit Programs Brochure .

Job Classification

Career Level: Mastery
FLSA: Nonexempt
Job Function: Research
Job Family: Clinical Research
Click here to learn more about Indiana University's Job Framework.

Posting Disclaimer

This posting is scheduled to close at 11:59 pm EST on the advertised Close Date. This posting may be closed at any time at the discretion of the University, but will remain open for a minimum of 5 business days. To guarantee full consideration, please submit your application within 5 business days of the Posted Date.
If you wish to include a cover letter, you may include it with your resume when uploading attachments.

Equal Employment Opportunity

Indiana University is an equal opportunity employer and provider of ADA services and prohibits discrimination in hiring. See Indiana University Notice of Non-Discrimination here which includes contact information .

Campus Safety and Security

The Annual Security and Fire Safety Report, containing policy statements, crime and fire statistics for all Indiana University campuses, is available online . You may also request a physical copy by emailing IU Public Safety at iups@iu.edu or by visiting IUPD.