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Job Description

The Clinical Research Coordinator II 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. Presents information at regular research staff meetings. May plan and coordinates strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities. 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.

• May coordinate training and education of other personnel.

• 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 staff 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.

Qualifications

Requirements:

• High School Diploma/GED required. Bachelors preferred

• 4 years of Clinical research related experience + 2 years assisting, supporting and/or participating in coordination of clinical research trials.

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Req ID : 1635

Working Title : Clinical Research Coordinator II, Castellon-Lopez Lab

Department : Cancer - Research Center Health Equity

Business Entity : Cedars-Sinai Medical Center

Job Category : Academic / Research

Job Specialty : Research Studies/ Clin Trial

Overtime Status : EXEMPT

Primary Shift : Day

Shift Duration : 8 hour

Base Pay : $28.30 - $48.11

Cedars-Sinai is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law.