Clinical Research Coordinator I - Guerin Children's Pediatric NICU - Full-T at Cedars-Sinai

Los Angeles, California, United States -

Full Time

Start Date

Immediate

Expiry Date

06 Aug, 26

Salary

39.76

Posted On

08 May, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Study Coordination, Patient Screening, Informed Consent, Data Collection, Case Report Forms, Regulatory Compliance, Patient Scheduling, Clinical Auditing, HIPAA Compliance, Good Clinical Practice

Industry

Hospitals and Health Care

Description

Come join our team! The Clinical Research Coordinator I works independently providing study coordination, 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 study information at regular research staff meetings. 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. * 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. * 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 perform 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. * Participates in required training and education programs. Cedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service. Today, Cedars- Sinai is known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow's health professionals. Additionally, Cedars-Sinai demonstrates a commitment to the community through programs that improve the health of its most vulnerable residents. Cedars-Sinai is one of the largest nonprofit academic medical centers in the U.S., with 886 licensed beds, 2,100 physicians, 2,800 nurses and thousands of other healthcare professionals and staff. Choose this if you want to work in a fast-paced environment that offers the highest level of care to people in the Los Angeles that need our care the most.

Responsibilities

The coordinator manages clinical study activities, including patient screening, informed consent, and data collection. They ensure strict compliance with FDA and IRB regulations while maintaining accurate source documentation and reporting study progress.