Pediatric Clinical Research Coordinator II

Cedars-Sinai; Los Angeles (CA); On-site; USD 65,000 - 90,000; Full time

Job summary

Cedars-Sinai in Los Angeles is seeking a Clinical Research Coordinator II to independently coordinate pediatric studies, including screening for protocol eligibility and guiding informed consent. You will manage data collection, source documentation, and timely reporting to sponsors.

Responsibilities include coordinating patient visits, maintaining CRFs, and ensuring compliance with FDA/IRB requirements while supporting training and process improvements to optimize enrollment and study quality.

Qualifications

• High School Diploma/GED required.
• Bachelor’s Degree in Science, Sociology or a related field preferred.
• Two years of clinical research experience required.
• SOCRA or ACRP certification preferred.

Responsibilities

• Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.
• Schedules patients for research visits and procedures.
• Documents on Case Report Forms (CRFs) changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
• Maintains accurate source documents related to all research procedures.
• Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
• Schedules and participates in monitoring and auditing activities.
• Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
• Notifies direct supervisor about concerns regarding data quality and study conduct.
• Works with regulatory staff/IRB to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters per guidelines.
• May perform other regulatory/IRB duties, budgeting duties, and assisting with patient research billing and reconciliation.
• Ensures compliance with FDA and IRB regulations and Good Clinical Practice (GCP).
• Maintains patient confidentiality per HIPAA and applicable laws.
• May coordinate training and education of other personnel.
• May participate in auditing and SOP development.
• May plan strategies for increasing patient enrollment and improving efficiency.

Education

High School Diploma/GED required.

Bachelor's Degree in Science, Sociology or related field preferred.

Job description

Cedars-Sinai in Los Angeles is seeking a Clinical Research Coordinator II to independently coordinate pediatric studies, including screening for protocol eligibility and guiding informed consent. You will manage data collection, source documentation, and timely reporting to sponsors.

Responsibilities include coordinating patient visits, maintaining CRFs, and ensuring compliance with FDA/IRB requirements while supporting training and process improvements to optimize enrollment and study quality.