When the work you do every single day has a crucial impact on the lives of others, every effort, every detail, and every second matters. This shared culture of happiness, passion, and dedication pulses through Cedars-Sinai.

We invite you to consider this phenomenal opportunity!

The Clinical Research Associate I will work directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and/or implement the study. This role evaluates and abstracts research data and ensures compliance with protocol and research objectives. The incumbent will be responsible for completing case report forms, entering clinical research data, and assists with regulatory submissions to the IRB. The CRA I team member will provide limited patient contact as needed for study, and will assist with study budget and patient research billing. The incumbent ensures compliance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.

Primary Job Duties and Responsibilities:

• Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
• Provides supervised patient contact or patient contact for long term follow-up patients only.
• Works closely with supervising research staff or directly with the Institutional Review Board to submit Adverse Events, Serious Adverse Events, and Safety Letters following local and federal guidelines.
• Schedules patients for research visits and research procedures.
• 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.
• 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.

Education:

• High School Diploma/G.E.D., required.
• Bachelor's degree in Science, Sociology, or related degree, preferred.

Licenses/Certifications:

• ACRP/SoCRA (or equivalent) certification is preferred.

Experience:

• One year of Clinical Research experience is required.
• Understanding of general research objectives.

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