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 Cedars-Sinai Center for Outcomes Research and Education (CS-CORE) is a group of academicians that supports high quality research efforts using a health services research model. Members of the center have published extensively in the fields of healthcare quality measurements, patient-reported outcome (PRO) development, healthcare decision making, health economics and digital health sciences.

About the Role

As a Clinical Research Associate I, you will work directly with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to assist in tasks supporting the coordination/implementation of non-complex research studies. The incumbent will support objectives of research studies through non-complex tasks such as data collection, prescreening and scheduling of current research participants, assisting in IRB submission activities, budget and billing, and ensuring overall compliance with all federal and local guidelines.

Primary Job Duties and Responsibilities:

• Collects, evaluates and/or abstracts clinical research data.
• May assist in designing forms for data collection/abstraction.
• Enters and processes clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
• Completes Case Report Forms (CRFs).
• Provides supervised patient contact or independent patient contact for long-term follow-up patients only.
• Assists supervising staff 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 and patient research billing.
• Responsible for sample preparation and shipping and maintenance of study supplies and kits.
• Ensures compliance with protocol and overall clinical research objectives.
• 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.
• May serve as one point of contact for external sponsors for select trials.
• May respond to sponsor inquiries and attend meetings regarding study activity under the direction of supervising staff.

Education:

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

Licenses/Certifications:

• ACRP/SoCRA certification is preferred.

Experience:

• Clinical research experience is highly preferred.
• Understanding of general research objectives.