Clinical Research Associate I - Clinical Trials Office

The Clinical Research Associate I works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and/or implement the study. Evaluates and abstracts research data and ensures compliance with protocol and research objectives. Responsible for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB. Provides limited patient contact as needed for study and assist with study budget and patient research billing. Ensures compliance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care

What Will You Be Doing

Works with a Clinical Research Coordinator, Research Program Administrator or Research Nurse to coordinate/implement study.

• Completes Case Report Forms (CRFs).
• Assists with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
• Assists with patient research billing.
• Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
• Evaluates and abstracts clinical research data from source documents.
• Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
• Participates in required training and education programs
• Assists with clinical trial budgets.
• Responsible for sample preparation and shipping and maintenance of study supplies and kits.
• Provides supervised patient contact or patient contact for long term follow-up patients only.
• Schedules patients for research visits and research procedures.
• Maintains research practices using Good Clinical Practice (GCP) guidelines.
• Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
• Ensures compliance with protocol and overall clinical research objectives.

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Requirements

• 1 year Clinical Research Related Experience preferred
• Phlebotomy Certification CA preferred
• High School Diploma/GED

Working Title: Clinical Research Associate I - Clinical Trials Office

Department: SOCCI Clinical Research Office

Business Entity: Cedars-Sinai Medical Center

Job Category: Academic/Research

Job Specialty: Research Studies/Clinical Trials

Position Type: Full-time

Shift Length: 8 hour shift

Shift Type: Day

Base Pay:$18.00 - $29.87