Clinical Research Associate I
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About The Position
The Clinical Research Associate I plays a crucial role in the coordination and implementation of clinical studies at Cedars-Sinai Medical Center. This position involves working closely with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to ensure that clinical trials are conducted in compliance with established protocols and research objectives. The Clinical Research Associate I is responsible for evaluating and abstracting research data, completing case report forms, and entering clinical research data into Electronic Data Systems (EDCs) provided by the sponsors. This role also includes assisting with regulatory submissions to the Institutional Review Board (IRB), which involves the submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines. In addition to data management, the Clinical Research Associate I provides limited patient contact as needed for the study, assists with study budgets, and manages patient research billing. The position requires strict adherence to federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care. The Clinical Research Associate I is also responsible for scheduling patients for research visits and procedures, preparing and shipping samples, and maintaining study supplies and kits. Participation in required training and education programs is essential to ensure compliance with Good Clinical Practice (GCP) guidelines and to maintain patient confidentiality according to HIPAA regulations. Overall, this position is integral to the successful execution of clinical trials, ensuring that all aspects of the research process are conducted ethically and in accordance with regulatory standards.
