Clinical Research Coordinator I -Surgery Chair

CEDARS-SINAI; Los Angeles (CA); On-site; USD 55,000 - 70,000; Full time

Job summary

Cedars-Sinai seeks a Clinical Research Coordinator I to independently coordinate studies in the Surgery Chair Department. You will screen patients for eligibility, assist with informed consent, ensure accurate data collection and CRF documentation, and support sponsor queries while maintaining regulatory compliance.

You will work with FDA/IRB processes, monitor adverse events, and collaborate with regulatory staff to ensure adherence to GCP and HIPAA. Strong organizational skills are essential.

Qualifications

• High School Diploma or GED required.
• Bachelor's Degree in Science, Sociology or related field preferred.
• 1 year of clinical research related experience required.
• SOCRA or ACRP certification preferred upon hire.
• Experience in FDA-regulated interventional trials and/or drug or cell therapy strongly desired.
• Experience with OnCore, Florence eBinders, Redcap or EDC systems is a bonus.

Responsibilities

• Independent study coordination including screening for protocol eligibility and assisting with informed consent.
• Schedule patients for research visits and procedures.
• Document thoroughly on Case Report Forms (CRFs) changes in patient condition, adverse events, and protocol compliance.
• Maintain accurate source documents for all research procedures.
• Data collection, documentation, entry and reporting; respond to sponsor queries in a timely manner.
• Coordinate monitoring and auditing activities.

Education

High School Diploma/GED

Bachelor's Degree in Science, Sociology or related degree

Tools

OnCore

Florence eBinders

Redcap

EDC system

Job description

Job Description

Come join our team! The Cedars-Sinai team is seeking a dynamic Clinical Research Coordinator to join the Surgery Chair Department.

The Clinical Research Coordinator I works independently providing study coordination, screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. Presents study information at regular research staff meetings. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).

Primary Duties and 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.
• In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; 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 closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
• May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
• Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
• Maintains research practices using Good Clinical Practice (GCP) guidelines.
• Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
• Participates in required training and education programs.

Qualifications

Education & Experience Requirements:

• High School Diploma/GED required.
• Bachelor's Degree in Science, Sociology or related degree preferred.
• One (1) year of clinical research related experience required.
• SOCRA or ACRP certification preferred upon hire.
• Prior experience in FDA-regulated interventional clinical trials and/or drug or cell therapy strongly desired.
• Experience working with OnCore, Florence eBinders, Redcap, EDC system is a bonus.