Clinical Research Coordinator II, Hybrid

Cedars-Sinai•Los Angeles, CA

13d•$29 - $49•Hybrid

About The Position

The Clinical Research Coordinator II independently coordinates clinical research studies, including screening potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. The coordinator is responsible for accurate and timely source documentation, data collection, entry, and reporting, including responding to sponsor queries. The role also compiles and reports study information such as protocol activity, accrual data, workload, and other research information, and presents this information at regular research staff meetings. The coordinator helps ensure compliance with federal and local requirements, including Food and Drug Administration (FDA) and Institutional Review Board (IRB) requirements, Good Clinical Practice (GCP) guidelines, and HIPAA and applicable confidentiality requirements. This role follows a hybrid work 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. The position may include coordinating personnel training, supporting regulatory and IRB activities, budgeting and patient research billing and reconciliation, developing enrollment or efficiency strategies, identifying quality improvement opportunities, and identifying new research opportunities.

Requirements

High school diploma or 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.
Ability to work a hybrid schedule with an expected on-site presence of 4 days per week.

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 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 on time, 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 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.
May perform regulatory and IRB duties, budgeting duties, and assist with patient research billing and reconciliation.
Ensure compliance with federal and local agencies and requirements, including FDA and IRB requirements.
Maintain research practices in accordance with Good Clinical Practice (GCP) guidelines.
Maintain 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 on action plans.
May identify new research opportunities and present them to investigators.
Participate in required training and education programs.