Clinical Research Coordinator II - Guerin Children's - Pediatric Neurology at Cedars-Sinai

Los Angeles, California, United States -

Full Time

Start Date

Immediate

Expiry Date

15 May, 26

Salary

100068.8

Posted On

14 Feb, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Study Coordination, Patient Screening, Informed Consent Process, Source Document Management, Data Collection, Data Entry, Sponsor Query Response, Protocol Activity Reporting, Accrual Data Reporting, Adverse Event Reporting, IRB Submission, FDA Compliance, HIPAA Compliance, Good Clinical Practice, Patient Enrollment Strategy, Clinical Research Efficiency

Industry

Hospitals and Health Care

Description

Come join our team! The Clinical Research Coordinator II 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). 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. May coordinate training and education of other personnel. May participate in centralized activities such as auditing, Standard Operating Procedure development, etc. May plan and coordinate strategies for increasing patient enrollment, and/or improving clinical research efficiency. 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. 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 Clinical Research Coordinator II independently manages study coordination, including screening patients, presenting trial details, and handling the informed consent process. Key duties involve accurate data collection, documentation, reporting, and ensuring timely responses to sponsor queries while maintaining compliance with regulatory guidelines.