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This role follows a hybrid work schedule; however, we can only consider applicants who will be able to commute to our Los Angeles work location a few times per week. If hired you must reside in the commutable area.

We are seeking a highly motivated and detail-oriented Clinical Research Coordinator I (CRC I) to support our clinical research operations. In this role, the CRC I will assist with the day-to-day coordination and execution of research protocols and clinical trials.

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

• Screen potential research participants to assess protocol eligibility.
• Schedule research visits and procedures for new and follow-up patients per study protocol.
• Ensure accurate and thorough documentation on Case Report Forms (CRFs).
• Maintain timely and organized source documentation.
• Collaborate with ancillary departments, including laboratory and pathology services, to support protocol requirements.
• Maintain research patient binders in compliance with regulatory standards.
• Provide administrative and clerical support related to active research projects.
• 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

This role follows a hybrid work schedule; however, we can only consider applicants who will be able to commute to our Los Angeles work location a few times per week. If hired you must reside in the commutable area.

Requirements:

• High School Diploma/GED required.
• 1 year Clinical research related experience required.

Preferred:

• Bachelor’s degree in a scientific or health-related field preferred.
• Previous experience in a clinical research setting is a plus.
• Strong organizational skills and attention to detail.
• Excellent communication and collaboration abilities.
• Familiarity with IRB protocols, GCP guidelines, and regulatory documentation is preferred.

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