Clinical Research Associate I

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

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

Requirements

• High School Diploma/GED

Preferred

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

Physical Demands
Standing, Walking, Sitting, Lifting 50 lbs. Carrying 50 lbs. Pushing 50 lbs. Pulling 50 lbs. Reaching, Handling, Grasping, Feeling, Talking, Hearing, Repetitive Motions, Eye/Hand/Foot Coordination
Working Title: Clinical Research Associate I
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