Clinical Research Coordinator II - Surgery Chair

Cedars-Sinai•Los Angeles, CA

19h•$60,028 - $102,044

About The Position

The Clinical Research Coordinator II independently coordinates clinical studies, including screening potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. The role schedules research visits and procedures and works with physicians and other medical personnel to document patient condition changes, adverse events, concomitant medication use, protocol compliance, and response to study drugs on Case Report Forms (CRFs). The coordinator maintains accurate source documents and is responsible for timely data collection, documentation, entry, and reporting, including responding to sponsor queries. The role compiles and reports study information such as protocol activity, accrual data, workload, and other research information, and presents it at regular research staff meetings. The coordinator also schedules and participates in monitoring and auditing activities and informs the direct supervisor of concerns about data quality or study conduct. The position supports regulatory compliance by working with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit adverse events, serious adverse events, protocol deviations, and safety letters according to local and federal guidelines. It ensures compliance with the Food and Drug Administration (FDA) and the IRB, follows Good Clinical Practice (GCP) guidelines, and protects patient confidentiality under HIPAA and applicable law. Additional duties may include regulatory and IRB work, budgeting, patient research billing and reconciliation, personnel training, centralized auditing or Standard Operating Procedure development, enrollment and efficiency strategies, quality improvement, and identifying research opportunities. Required training and education programs must be completed.

Requirements

High School Diploma or GED required.
Two years of clinical research-related experience required.

Nice To Haves

Bachelor's degree in science, sociology, or a related field preferred.
SOCRA or ACRP certification preferred.

Responsibilities

Independently coordinate studies, screen potential patients for protocol eligibility, present non-medical trial concepts and details, and participate in the informed consent process.
Schedule patients for research visits and procedures.
Collaborate with physicians and other medical personnel to document patient condition changes, adverse events, concomitant medication use, protocol compliance, and response to study drugs on Case Report Forms (CRFs).
Maintain accurate source documents related to research procedures.
Collect, document, enter, and report study data accurately and promptly, including responding to sponsor queries in a timely manner.
Schedule and participate in monitoring and auditing activities.
Compile and report study information, including protocol activity, accrual data, workload, and other research information, and present it at regular research staff meetings.
Notify the direct supervisor of concerns about data quality or study conduct.
Work with a regulatory coordinator or directly with the IRB to submit adverse events, serious adverse events, protocol deviations, and safety letters in accordance with local and federal guidelines.
Ensure compliance with FDA and IRB requirements, follow GCP guidelines, and maintain patient confidentiality under HIPAA and applicable law.
May perform regulatory or IRB duties, budgeting, and patient research billing and reconciliation.
May coordinate training and education for other personnel and participate in centralized activities such as auditing and Standard Operating Procedure development.
May plan and coordinate strategies to increase patient enrollment or improve clinical research efficiency.
May identify quality and performance improvement opportunities and collaborate with staff on action plans.
May identify new research opportunities and present them to investigators.
Participate in required training and education programs.