Cedars-Sinai Clinical Research Coordinator I in Los Angeles, California

Job Posting: JOB SUMMARY: The Clinical Research Coordinator I works independently providing study coordination including 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; present this 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). ESSENTIAL JOB 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. Scheduling of 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 involve 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 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. May identify quality and performance improvement opportunities and collaborate with sta 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.

Qualification Requirements/Preferences:

Education Certifications/Licensure Experience Physical Abilities EDUCATION AND EXPERIENCE REQUIREMENTS:

Education:

BA/BS degree.

Certification/License:

ACRP/SoCRA (or equivalent) certification preferred. Experience:

Two (2) years of directly related experience,

DEPARTMENT AND/OR UNIT SPECIFIC — ESSENTIAL JOB RESPONSIBILITIES:

Independent study coordination to support the Women's Cancer Program Biorepository and the Gilda Radner Hereditary Cancer Program including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and consenting patients to low-risk studies.

Independent communication with patients and scheduling of patients for research visits and procedures.

Thoroughly documents patient medical history, specimen collection data, adverse events, concomitant medication use, and protocol compliance. This includes specimen documentation for the Women's Cancer Program biorepository, the Gilda Radner Program, and all other specimen related research such as CPTAC, OCAC, and CIMBA.

Provides back-up for specimen processing in support of the Women's Cancer Program biorepository and the Gilda Radner Program