Clinical Research Coordinator I, Salvy Lab

1 day ago

Fresno County CA United States CEDARS-SINAI Full time

Job Description

This role is based in Los Angeles, California, and requires an onsite presence. Candidates will need to relocate to the area if an offer is extended. We're seeking individuals ready to join our dynamic team and contribute in person at our LA office.
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.
* 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

Qualifications

Requirements:

* High School Diploma/GED required. Bachelor's Degree preferred.
* 1 year Clinical research related experience required.

#Jobs-Indeed
Req ID : 5931
Working Title : Clinical Research Coordinator I, Salvy Lab (Onsite)
Department : Cancer - Research Center Health Equity
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : NONEXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $23.39 - $39.76

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