Clinical Research Coordinator I - Dept of Orthopaedics

Cedars-Sinai•Los Angeles, CA

4d•$24 - $40•Onsite

About The Position

Cedars-Sinai, an organization recognized for its high-quality medical care and employee engagement, is seeking a Clinical Research Coordinator I for the Department of Orthopaedics. This role involves independent study coordination, patient screening for protocol eligibility, explaining trial details, and managing the informed consent process. The position requires meticulous attention to detail in creating and maintaining source documents, collecting and entering data accurately and promptly, and responding to sponsor queries. The coordinator will compile and report on study progress, including protocol activity, accrual data, and workload, presenting this information at staff meetings. A key aspect of the role is ensuring strict adherence to all federal and local regulations, including those set by the Food and Drug Administration (FDA) and local Institutional Review Boards (IRB), and maintaining research practices according to Good Clinical Practice (GCP) guidelines and HIPAA regulations.

Requirements

Independent study coordination
Screening of potential patients for protocol eligibility
Presenting non-medical trial concepts and details to patients
Participating in the informed consent process
Accurate and timely source documents
Data collection, documentation, entry, and reporting
Timely response to sponsor queries
Compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information
Presenting study information at regular research staff meetings
Ensuring compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB)
Maintaining research practices using Good Clinical Practice (GCP) guidelines
Maintaining strict patient confidentiality according to HIPAA regulations and applicable law
Participating in required training and education programs

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.