Clinical Research Coordinator, Pediatric Endocrinology/Diabetology

Department

PED-ENDOCRINOLOGY/DIABETOLOGY (IN-PEND-IUINA)

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 will be 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. It 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, 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 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

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

LICENSES AND CERTIFICATES

Preferred

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

SKILLS

Required

• Demonstrates analytical skills
• Ability to simultaneously handle multiple priorities
• Possesses strong technical aptitude
• Demonstrates a high commitment to quality
• Excellent organizational skills

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

$50,000 - $60,000 based on experience

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 and 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: Core

FLSA: Exempt

Job Function: Research

Job Family: Clinical Research

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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.

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