Pediatric Clinical Research Coordinator

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

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.