Clinical Research Coordinator II – Clinical Trials

Cedars-Sinai•Los Angeles, CA

8d•$29 - $49•Hybrid

About The Position

This role follows a hybrid schedule, with 4 days onsite and 1 day remote. The schedule may require additional onsite presence based on patient needs, study activities, and operational priorities. This is an opportunity to join an incredible team of staff and physicians who are committed to improving the lives of patients through meaningful clinical research. The team values collaboration, celebrates wins and achievements, and supports one another in delivering high-quality patient care and study outcomes.

Requirements

Prior treatment experience as a Clinical Research Coordinator.
Experience coordinating clinical trials across multiple electronic data capture (EDC) systems.
Comfortable managing study data, documentation, and timelines with accuracy and attention to detail.

Nice To Haves

Oncology experience

Responsibilities

Works independently providing study coordination including 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 information at regular research staff meetings.
May plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities.
Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
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.
Schedules and participates in monitoring and auditing activities.
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.
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains 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, Standard Operating Procedure development, etc.
May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
May identify new research opportunities and present to investigators.
Participates in required training and education programs.