Clinical Research Associate I - Regenerative Medicine Institute

Join us as we translate today's discoveries, into tomorrow's medicine!

Regenerative medicine is a new and developing field that aims to restore function in diseased or aged tissues through either revitalizing existing cells or transplanting new ones. At the Board of Governors Regenerative Medicine Institute, researchers are turning stem cells into therapies for treating a multitude of prevalent diseases and conditions. We're also exploring how to prevent diseases, and we're extending our knowledge to students in Los Angeles and researchers around the world. To learn more, please visit Board of Governors Regenerative Medicine Institute | Cedars-Sinai

Are you ready to be a part of breakthrough research?

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. Evaluates and abstracts research data and ensures compliance with protocol and research objectives. Responsible for completing case report forms, entering clinical research data, and assisting with regulatory submissions to the IRB. Provides limited patient contact as needed for study and assists with study budget and patient research billing. Ensures compliance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations about the study and patient care.

Primary Duties & Responsibilities:

• Works with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate/implement the study.
• Evaluates and abstracts clinical research data from source documents.
• Ensures compliance with protocol and overall clinical research objectives.
• 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 per 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.

Education:

• High School Diploma is required. A bachelor's degree in Science, Sociology, or a related field is preferred.

Experience and Skills:

• Understanding of​ general clinical research objectives. One (1) year of clinical research experience is preferred.
• Ability to interpret and apply knowledge of State, Federal, and Agency standards to comply with regulations.
• Must possess computer skills, including Word and Excel, and the ability to use standard office equipment is required.