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Cedars-Sinai · 3 days ago

Clinical Research Coordinator II - Guerin Children's - Developmental-Behavioral Pediatrics - Full-Time, On-Site, Days

Los Angeles, CA

Full-time

Onsite

Entry, Mid Level

$59K/yr - $100K/yr

2+ years exp

Cedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. The Clinical Research Coordinator II works independently to provide study coordination, including screening patients for eligibility, data collection, documentation, and ensuring compliance with research protocols.

CommunitiesHealth CareMedicalNon Profit

Comp. & Benefits

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

Qualification

Clinical research experienceSOCRAACRP certificationGene therapy trialsClinical trial budgetingRegulatory complianceClinical Practice (GCP)Patient confidentialityTraining coordination

Required

High School Diploma/GED required

Two (2) years of clinical research related experience required

Preferred

Bachelor's Degree in Science, Sociology or related degree preferred

SOCRA or ACRP certification preferred

Experience with gene therapy clinical trials and pediatric populations preferred

Experience with clinical trial budgeting and regulatory for FDA-regulated therapeutics preferred

Company

Cedars-Sinai

Glassdoor4.0

Since its beginning in 1902, Cedars-Sinai has evolved to meet the healthcare needs of one of the most diverse regions in the nation, continually setting new standards for quality and innovation in patient care, research, teaching and community service.

Founded in 1902

Los Angeles, California, USA

10001+ employees