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Cedars-Sinai · 2 months ago

Clinical Research Coordinator III - Cardiology Research - Makkar Lab

127 S San Vicente Blvd, Los Angeles, CA, 90048, US

Full-time

Onsite

Senior Level

$34.24/hr - $58.21/hr

Cedars-Sinai is dedicated to heart disease and research innovation, providing patients with access to top-tier care. The Clinical Research Coordinator III will independently manage study coordination, oversee research staff, and ensure compliance with regulatory standards while enhancing patient enrollment and research efficiency.

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

Scheduling of 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 involve 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

Works with Training and Education Coordinator to ensure all staff is properly trained and certified

Participate in centralized activities such as auditing, Standard Operating Procedure development, etc

Plans and coordinates strategies for increasing patient enrollment, and/or improving clinical research efficiency

Identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality

Identifies new research opportunities and presents to investigators

Supervises other research staff

Qualification

Clinical Research CoordinationClinical Practice (GCP)FDA ComplianceData CollectionPatient Enrollment StrategiesSupervision of StaffRegulatory SubmissionsHIPAA ComplianceTrainingEducation

Required