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. Join Cedars-Sinai and become part of a team that is at the forefront of medical advancements! The Cedars-Sinai Biomedical Imaging Research Institute (BIRI) is an interdisciplinary research program established to develop and apply state-of-the-art imaging technologies to today???s most pressing translational research and clinical questions.

As part of the Biomedical Imaging Research Institute, research in the Dey Laboratory focuses on automated derivation of imaging measures from noninvasive cardiac image data, clinical implementation of novel automated computer processing algorithms, and the application of these tools to solve key clinical problems. To learn more, please visit: Dey Research Lab | Cedars-Sinai (cedars-sinai.edu)

Are you ready to be a part of breakthrough research?

The Clinical Research Associate I works 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 assist with regulatory submissions to the IRB. Provides limited patient contact as needed for study and assist 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:

• Works with a Clinical Research Coordinator, Research Program Administrator or Research Nurse to coordinate/implement 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 the sponsors provide.
• 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.
• Performs quantitative analysis on cardiovascular CT and other images, including segmentation, registration, and volumetrics.

Education:

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

Experience and Skills:

• One (1) year of clinical research and cardiac CT experience is preferred. Understanding of general clinical research objectives.
• 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.