Clinical Research Associate I, Rosser

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.
Primary Duties And Responsibilities

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

Requirements

• High School Diploma/GED required

Preferred

• 1 year of Clinical Research Related Experience preferred
• Bachelor's Degree Degree in Science, Sociology or related degree preferred

Working Title: Clinical Research Associate I, Rosser
Department: Home Dept - Hem - Onc
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