Clinical Research Coordinator III (Hybrid) at Cedars-Sinai

Los Angeles, California, United States -

Full Time

Start Date

Immediate

Expiry Date

16 Jul, 26

Salary

58.21

Posted On

17 Apr, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical research coordination, Patient screening, Informed consent process, Data collection, Case report forms, Regulatory compliance, FDA regulations, IRB submission, Good clinical practice, HIPAA compliance, Staff supervision, Patient enrollment, Quality improvement, Adverse event reporting, Protocol compliance

Industry

Hospitals and Health Care

Description

This role follows a hybrid work schedule; however, we can only consider applicants who will be able to commute to our Los Angeles work location a few times per week. If hired you must reside in the commutable area. The Clinical Research Coordinator III 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 oversight of all studies with the group and the assignment of studies to clinical research personnel within the group, and supervision of research staff. Plans and coordinates strategies for increasing patient enrollment, improving efficiency, training of personnel, and 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) Primary Duties and Responsibilities * Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process. * Scheduling of 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. * Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries. * Schedules and participates in monitoring and auditing activities. * Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings. * 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 involve other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation. * Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board. * Maintains research practices using Good Clinical Practice (GCP) guidelines. * Maintains strict patient confidentiality according to HIPAA regulations and applicable law. * Works with Training and Education Coordinator to ensure all staff is properly trained and certified. * Participate in centralized activities such as auditing, Standard Operating Procedure development, etc. * Plans and coordinates strategies for increasing patient enrollment, and/or improving clinical research efficiency. * Identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality. * Identifies new research opportunities and presents to investigators. * Supervises other research staff.

Responsibilities

The Clinical Research Coordinator III independently manages study coordination, including patient screening, informed consent, and data documentation. They are also responsible for supervising research staff, ensuring regulatory compliance, and developing strategies to improve patient enrollment and research efficiency.