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 Lung Institute investigates many lung diseases to discover pathological causes and determine how regenerative medicine can improve patient outcomes. The team provides comprehensive inpatient and outpatient care at Cedars-Sinai for diseases of the esophagus, chest, lungs and airways. The Lung Institute Biobank at Cedars-Sinai Medical Center collects variety of respiratory and non-respiratory bio-specimens from patients for high quality basic and translational research.

As a Clinical Research Associate I, you will work directly with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to coordinate and/or implement the study. This role evaluates and abstracts research data, and ensures compliance with protocol and research objectives. This position is responsible for completing case report forms (CRFs), entering clinical research data, and assisting with regulatory submissions to the Institutional Review Board (IRB). The CRA I may have limited contact with research participants as needed for study and assists with study budget and research participant billing. This role follows all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.

Primary Job Duties and Responsibilities:

• Completes Case Report Forms (CRFs).
• 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.
• 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 clinical trial budgets.
• Assists with patient research billing.
• 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.
• Coordinates bio-specimen requests by research investigators.

Education:

• High School Diploma/GED is required.
• Bachelor's degree in Science, Sociology, or related degree is preferred.

Licenses/Certifications:

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

Experience:

• One year of clinical research or coordinating clinical research trials experience is preferred.