Clinical Research Coordinator II, Hybrid

Cedars-Sinai•Beverly Hills, CA

12d•$29 - $49•Hybrid

About The Position

The Clinical Research Coordinator II works independently to coordinate clinical studies, including screening potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in informed consent. The role is responsible for accurate and timely source documentation, data collection, documentation, entry, and reporting, including responses to sponsor queries. It also compiles and reports study information such as protocol activity, accrual data, and workload, and presents updates at regular research staff meetings. The coordinator may develop strategies to increase enrollment and efficiency, train personnel, identify research opportunities, and support quality improvement. The role ensures compliance with federal and local requirements, including FDA and Institutional Review Board requirements, follows Good Clinical Practice guidelines, and protects patient confidentiality under HIPAA and applicable law. The position follows a hybrid schedule, with an expected on-site presence of four days per week. Applicants must be able to commute to the Los Angeles work location and, if hired, reside within a commutable distance.

Requirements

High School Diploma/GED (minimum).
At least 2 years of clinical research-related experience.
Ability to commute to the Los Angeles work location and reside within a commutable distance if hired.

Nice To Haves

Bachelor's degree in Science, Sociology, or a related field.
SOCRA or ACRP certification.

Responsibilities

Independently coordinate studies, including screening potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in informed consent.
Schedule patients for research visits and procedures.
In collaboration with physicians and other medical personnel, document changes in patient condition, adverse events, concomitant medication use, protocol compliance, and response to study drug on Case Report Forms (CRFs).
Maintain accurate source documents related to all research procedures.
Ensure accurate and timely data collection, documentation, entry, and reporting, including timely responses to sponsor queries.
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 regarding data quality and 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.
May perform regulatory and IRB duties, budgeting duties, and assist with patient research billing and reconciliation.
Ensure compliance with federal and local agencies, including the FDA and local IRB.
Maintain research practices in accordance with Good Clinical Practice (GCP) guidelines.
Maintain strict patient confidentiality according to HIPAA regulations and applicable law.
May coordinate training and education of other personnel.
May 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 to develop action plans.
May identify new research opportunities and present them to investigators.
Participate in required training and education programs.