Clinical Research Coordinator, Pediatric Endocrinology/Diabetology

Indiana University; Indianapolis (IN); On-site; USD 58,000 - 68,000; Full time

Benefits offered by this job

Comprehensive medical and dental保险

Health savings account

Tuition subsidy for employees

Paid holidays and paid time off

Job summary

Indiana University in Indianapolis seeks a Clinical Research Coordinator to support the pediatric research portfolio. The role coordinates studies from start-up through reporting, manages participant screening, visits, assessments, and regulatory files, and works with investigators to ensure protocol and GCP compliance.

Responsibilities include safeguarding data quality, monitoring enrollment, and assisting with budget negotiations.

Qualifications

• Bachelor's degree in science or health-related field and 2 years of clinical research experience, OR Associate's degree in science or health-related field and 3 years of clinical research experience.
• SOCRA/ACRP clinical research certification preferred at date of hire.
• Demonstrates analytical skills and ability to handle multiple priorities.
• Possesses strong technical aptitude and a high commitment to quality.
• Excellent organizational skills and attention to detail.

Responsibilities

• Coordinate study start-up, ongoing activities, protocol review, risk assessment, timelines, enrollment goals, and issue resolution.
• Identify and screen potential participants; conduct interviews, visits, assessments, and non-medical procedures; coordinate follow-up with participants and care teams.
• Prepare and maintain IRB and sponsor regulatory documents; ensure GCP and protocol compliance; review adverse events and report deviations.
• Maintain accurate study records; assist with budget negotiations and account reconciliation.
• Initiate protocol reviews, evaluations, study design, and risk assessments; monitor enrollment and adjust recruitment as needed.
• Oversee regulatory filings, organize electronic files, and prepare informed consent materials and other regulatory documents.

Skills

Analytical skills

Multi-tasking

Technical aptitude

Quality orientation

Organizational skills

Education

Bachelor's degree in science or health-related field

2 years clinical research experience

Associate's degree in science or health-related field

3 years clinical research experience

Job description

PED-ENDOCRINOLOGY/DIABETOLOGY (IN-PEND-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.

The Clinical Research Coordinator supports the unit's clinical research portfolio by coordinating studies from start-up through reporting. The role manages participant screening, recruitment, visits, and assessments; maintains regulatory files; and works with investigators and study teams to ensure protocol and Good Clinical Practice (GCP) compliance. The coordinator monitors enrollment follows up on safety events, and reports protocol deviations to protect participants and support data quality.

Department-Specific Responsibilities

• Coordinate study start-up and ongoing activities, review protocols, support study design and risk assessment, track timelines and enrollment goals, and resolve operational issues.
• Identify and screen potential participants; conduct interviews, visits, assessments, and protocol-required non-medical procedures; and coordinate follow-up with participants and care teams.
• Prepare and maintain Institutional Review Board (IRB) and sponsor regulatory documents; ensure compliance with protocols, institutional requirements, and GCP; review and follow up on adverse events; and document and report protocol deviations and study changes.
• Maintain accurate study records, follow up with investigators and other stakeholders, report study progress, and assist with budget negotiations and account reconciliation.

General Responsibilities

• Initiate and conduct protocol review, evaluations, study design, and risk assessments of clinical research studies.
• Participate in study budget negotiations and reconcile study budget accounts.
• Develop informational materials for recruitment of subjects. Monitor enrollment goals and modifies recruitment strategy as needed.
• Oversee and ensure compliance with regulations, including organizing electronic files and/or filing regulatory documents appropriately. Prepare and submit IRB documents (i.e., Informed Consent, advertisement, protocol and protocol summary). Prepare regulatory documents for sponsor.
• Identify and select potential subjects by reviewing existing protected health information, screening subjects, and conducting interviews. Perform subject interviews and assessments for data required by protocol(s).
• Follow up on study documentation with necessary stakeholders (healthcare providers, study participants, laboratory personnel, etc.).
• Review 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.
• Conduct study-related non-medical/behavioral assessments/interventions as well as study procedures/interventions (appropriate licensure may apply).
• Record, document, and report protocol deviations and trial changes to PI and sub-investigators.
• Stay 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.

Required

EDUCATION / WORK EXPERIENCE

• 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.

Preferred

• SOCRA/ACRP clinical research certification upon date of hire.

Skills

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

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.

This position is not eligible for visa sponsorship.

Indianapolis, Indiana

$58,000.00 - $68,000.00 annually determined by education, experience, knowledge, skills, and abilities, as required by the role, as well as internal equity and alignment with market data.

Benefits

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.

Career Level: Career

FLSA: Exempt

Job Function: Research

Job Family: Clinical Research

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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