Clinical Research Coordinator II, Hybrid

Cedars-Sinai Medical Center•Beverly Hills, CA

1d•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 the informed consent process. The role maintains accurate and timely source documents and is responsible for collecting, documenting, entering, and reporting study data, including responding to sponsor queries. It also compiles and reports study information such as protocol activity, accrual data, workload, and other research information, and presents information at regular research staff meetings. The position helps ensure studies comply with federal and local requirements, including FDA and Institutional Review Board (IRB) requirements, and follows Good Clinical Practice guidelines and HIPAA confidentiality requirements. The role may also support regulatory and IRB duties, budgeting, research billing and reconciliation, personnel training, quality improvement, enrollment strategies, and identification of new research opportunities. This role follows a hybrid schedule with at least four days onsite each week at the Los Angeles work location. Applicants must be able to meet this onsite requirement and, if hired, reside within commuting distance.

Requirements

High school diploma or GED.
At least 2 years of clinical research-related experience.

Nice To Haves

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

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.
Work with physicians and other medical personnel to document patient condition changes, 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.
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 about 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.
Ensure compliance with applicable federal and local requirements, including FDA and IRB requirements.
Maintain research practices in accordance with Good Clinical Practice guidelines and protect patient confidentiality under HIPAA and applicable law.
Participate in required training and education programs.
May perform other regulatory or IRB duties, budgeting duties, and assist with patient research billing and reconciliation.
May coordinate training and education for 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 on action plans.
May identify new research opportunities and present them to investigators.