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Cedars-Sinai · 3 months ago

Clinical Research Coordinator I, Castellon-Lopez Lab

6500 Wilshire Blvd, Los Angeles, CA, 90048, US

Full-time

Onsite

New Grad, Entry Level

$23.39/hr - $39.76/hr

Cedars-Sinai is a renowned healthcare institution, and they are seeking a Clinical Research Coordinator I to join the Castellon-Lopez Lab. This role involves independent study coordination, patient screening for protocol eligibility, data collection, and ensuring compliance with regulatory standards.

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

Participates in required training and education programs

Qualification

Clinical Research CoordinationData CollectionClinical Practice (GCP)FDA ComplianceIRB SubmissionPatient ConfidentialityCommunication Skills

Required