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Are you ready to be a part of breakthrough research?

The Biomedical Imaging Research Institute (BIRI) is an interdisciplinary research program dedicated to developing and applying state???of-the-art imaging technologies to today???s most pressing translational research and clinical questions. Our team collaborates closely with physicians and leading imaging researchers worldwide, uniting technical and clinical expertise in cardiology, neurology and oncology. We prioritize educating and training future imaging leaders. To learn more, please visit Biomedical Imaging Research Institute | Cedars-Sinai.

We are seeking a Clinical Research Associate I (CRAI) who will work directly with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to coordinate and/or implement the study. The CRAI evaluates and abstracts research data and ensures compliance with protocol and overall clinical research objectives. This role is responsible for completing case report forms (CRFs) and entering clinical research data, as well as providing limited contact with research participants 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 pertaining to the study and patient care.

Primary Duties & 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.
• 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.
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Education:

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

Experience and Skills:

• Understanding of??? general clinical research objectives. Clinical research experience is preferred.
• Ability to interpret and apply knowledge of State, Federal, and Agency standards to comply with regulations.
• Ability to convey and/or receive written/verbal information to/from various audiences in different formats.