Clinical Research Coordinator II, Hybrid

Cedars-Sinai Medical Center•Beverly Hills, CA

11d•Hybrid

About The Position

The Clinical Research Coordinator II independently coordinates clinical studies, including screening potential participants for protocol eligibility, explaining non-medical trial concepts and details, and participating in the informed consent process. The coordinator schedules research visits and procedures, maintains accurate source documents, and ensures timely collection, documentation, entry, and reporting of study data, including responses to sponsor queries. The role collaborates 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. It compiles and reports study information such as protocol activity, accrual data, and workload, and presents that information at regular research staff meetings. The coordinator schedules and participates in monitoring and auditing activities and alerts the direct supervisor to concerns about data quality or study conduct. The position works with a regulatory coordinator or directly with the Institutional Review Board to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with applicable guidelines. It may also involve other regulatory or IRB duties, budgeting, patient research billing and reconciliation, training personnel, centralized auditing and Standard Operating Procedure development, and efforts to improve enrollment, efficiency, quality, and research opportunities. The coordinator ensures compliance with federal and local requirements, including those of the FDA and local IRB, follows Good Clinical Practice guidelines, and maintains patient confidentiality under HIPAA and applicable law. The role 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 reside within commuting distance if hired.

Requirements

High school diploma or GED (minimum education requirement).
At least 2 years of clinical research-related experience.
Ability to commute to the Los Angeles work location and reside within commuting distance if hired.
Ability to work a hybrid schedule with an expected on-site presence of four days per week.

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 informed consent.
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.
Maintain accurate source documents related to research procedures.
Collect, document, enter, and report data accurately and on time, including responding to sponsor queries promptly.
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 guidelines.
Ensure compliance with federal and local agencies and requirements, including the FDA and local IRB.
Maintain research practices consistent with Good Clinical Practice guidelines and protect patient confidentiality under HIPAA and applicable law.
Participate in required training and education programs.
As needed, perform regulatory or IRB duties, budgeting, and patient research billing and reconciliation.
As needed, coordinate training and education of personnel and participate in centralized activities such as auditing and Standard Operating Procedure development.
As needed, plan and coordinate strategies to increase patient enrollment or improve clinical research efficiency.
As needed, identify quality and performance improvement opportunities and collaborate with staff on action plans.
As needed, identify new research opportunities and present them to investigators.