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Cedars-Sinai · 1 month ago

Clinical Research Coordinator II – Head & Neck (Hybrid Role)

120 N Robertson Blvd, Los Angeles, CA, 90048, US

Full-time

Hybrid

Mid Level

$28.30/hr - $48.11/hr

Cedars-Sinai is a leading healthcare institution, and they are seeking a Clinical Research Coordinator II for their Head & Neck department. This role involves coordinating clinical studies, ensuring compliance with regulations, and managing data collection and reporting for research activities.

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. Primary Duties and Responsibilities

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

Verifies specimen identification and assesses the appropriateness of test orders and specimen quality by recognizing factors that may affect procedures or results; takes corrective action when necessary

Ensures accurate patient and specimen identification through strict adherence to established procedures; labels all samples accurately and completely

Reports test results to the appropriate individuals and maintains strict professional discretion with all patient information

Transports research medications in accordance with established protocols

Performs research-related assessments and administers study questionnaires

Assists with prescreening of potential research participants for various clinical trials

Participates in research meetings and monthly sponsor conference calls for study updates

Maintains well-organized paper and electronic research files

Conducts all data collection and data entry activities for department clinical trials

Assists in preparing manuscripts, letters, and other research documents as needed

Responds to sponsor inquiries regarding protocol start-up and participant recruitment activities

Conducts literature reviews to support research activities

Assists with budget development and negotiation in collaboration with CTAO and study sponsors, ensuring full compliance with all CSMC policies

May support the training and education of other personnel as needed

Qualification

Clinical Research CoordinationClinical Practice (GCP)Data CollectionRegulatory CompliancePatient Enrollment StrategiesPatient ConfidentialityTrainingEducationLiterature Reviews

Required

Schedules patients for research visits and procedures

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

Notifies direct supervisor about concerns regarding data quality and study conduct

Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board