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Cedars-Sinai · 1 day ago

Surgery Chair Clinical Research Coordinator II

California, United States

Full-time

Onsite

Entry, Mid Level

$59K/yr - $100K/yr

2+ years exp

Cedars-Sinai is seeking a Clinical Research Coordinator II to join their team. This role involves independent study coordination, ensuring compliance with federal regulations, and managing data collection and reporting for clinical trials.

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 experienceClinical Practice (GCP)Data collectionStudy coordinationRegulatory complianceSOCRA certificationACRP certificationHIPAA regulationsPatient confidentialityTraining personnel

Required

High School Diploma/GED

Two (2) years of clinical research related experience

Preferred

Bachelor's Degree in Science, Sociology or related degree

SOCRA or ACRP certification

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