Job detail

Clinical Research Coordinator I, Castellon-Lopez Lab

Cedars-Sinai

#HIPAA #Regulatory Compliance #FDA #Clinical Research #GCP #Data Collection #Informed Consent #Clinical Trials #Case Report Forms

Quick overview

The Clinical Research Coordinator manages study protocols, including patient screening, informed consent, and data collection. They ensure compliance with FDA and IRB regulations while maintaining accurate source documentation and reporting study progress.

Requirements summary

Candidates must have a high school diploma or GED and at least one year of clinical research experience. A bachelor's degree in science is preferred.

high schoolbachelor degreeHIPAA ComplianceRegulatory ComplianceData EntryData CollectionClinical ResearchPatient SchedulingInformed ConsentPatient ScreeningProtocol ComplianceGood Clinical PracticeFDA RegulationsStudy CoordinationAdverse Event ReportingCase Report FormsIRB Submission

Job description

The Clinical Research Coordinator I works independently providing study coordination, screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process.
Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries.
Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information.
Presents study information at regular research staff meetings.
Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).

Primary Duties and 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.

Clinical Research Coordinator I, Castellon-Lopez Lab

Quick overview

Requirements summary

Job description

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