Cedars-Sinai
Clinical Research Coordinator I, Castellon-Lopez Lab
Cedars-Sinai, Los Angeles, California, United States, 90079
Clinical Research Coordinator I, Castellon‑Lopez Lab
Responsible for study coordination, screening patients for protocol eligibility, presenting trial concepts, and participating in the informed consent process. Maintains accurate source documents, collects and documents data, enters and reports information in a timely manner, and responds to sponsor queries. Compiles and reports on each study, presenting protocol activity, accrual data, workload, and other research information at regular research staff meetings. Ensures compliance with all federal and local agencies, including FDA and local IRB, and follows Good Clinical Practice (GCP) guidelines.
Primary Duties And Responsibilities
Independent study coordination, including screening patients for protocol eligibility and presenting trial concepts.
Schedules patients for research visits and procedures.
Documents patient condition, adverse events, concomitant medication, protocol compliance, and response to study drug on Case Report Forms (CRFs).
Maintains accurate source documents related to all research procedures.
Collects, documents, enters, and reports data, responding to sponsor queries in a timely manner.
Participates in monitoring and auditing activities.
Compiles and reports protocol activity, accrual data, workload, and other research information; presents this information at regular research staff meetings.
Notifies supervisor of concerns regarding data quality and study conduct.
Submits Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters to FDA and IRB according to local and federal guidelines.
Assists with budgeting duties, patient research billing, and reconciliation.
Ensures compliance with FDA, local IRB, and GCP guidelines.
Maintains strict patient confidentiality under HIPAA regulations.
Participates in required training and education programs.
Qualifications
High School Diploma/GED required.
1 year clinical research related experience required.
Preferred
Bachelor's Degree in Science.
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Primary Duties And Responsibilities
Independent study coordination, including screening patients for protocol eligibility and presenting trial concepts.
Schedules patients for research visits and procedures.
Documents patient condition, adverse events, concomitant medication, protocol compliance, and response to study drug on Case Report Forms (CRFs).
Maintains accurate source documents related to all research procedures.
Collects, documents, enters, and reports data, responding to sponsor queries in a timely manner.
Participates in monitoring and auditing activities.
Compiles and reports protocol activity, accrual data, workload, and other research information; presents this information at regular research staff meetings.
Notifies supervisor of concerns regarding data quality and study conduct.
Submits Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters to FDA and IRB according to local and federal guidelines.
Assists with budgeting duties, patient research billing, and reconciliation.
Ensures compliance with FDA, local IRB, and GCP guidelines.
Maintains strict patient confidentiality under HIPAA regulations.
Participates in required training and education programs.
Qualifications
High School Diploma/GED required.
1 year clinical research related experience required.
Preferred
Bachelor's Degree in Science.
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