Job Description

Clinical Research Coordinator I, Goodman Lab (Hybrid) at CEDARS-SINAI summary:

The Clinical Research Coordinator I independently manages clinical study coordination, including patient screening for eligibility, informed consent participation, and data collection. They ensure compliance with federal and local regulations such as FDA and IRB requirements, maintain accurate documentation, and communicate study information to stakeholders. Additionally, they support monitoring activities, regulatory submissions, and maintain confidentiality under HIPAA guidelines.

Job Description

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

Job qualifications

• High School Diploma/GED required. Bachelor's Degree Science, Sociology or related degree preferred.
• 1 year of experience of Clinical research related experience required.
• Phlebotomy Certification CA required.

Req ID : 8563
Working Title : Clinical Research Coordinator I, Goodman Lab (Hybrid)
Department : Cancer - SOCCI Clinical Research
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

Keywords:

clinical research coordinator, study coordination, patient screening, protocol eligibility, informed consent, data collection, FDA compliance, IRB regulations, clinical trials, Good Clinical Practice

Job Tags

Full time, Local area, Shift work,

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