The Clinical Research Associate I supports clinical trials by coordinating study activities, ensuring adherence to protocols, abstracting research data, and assisting with regulatory submissions. This role involves limited patient contact, data entry into electronic systems, and compliance with FDA, IRB, and HIPAA regulations. Additionally, the position assists with budgeting, patient billing, sample management, and maintaining good clinical practice standards.
This role follows a hybrid work schedule; however, we can only consider applicants who will be able to commute to our Los Angeles work location a few times per week. If hired you must reside in the commutable area.
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 and Responsibilities
This role follows a hybrid work schedule; however, we can only consider applicants who will be able to commute to our Los Angeles work location a few times per week. If hired you must reside in the commutable area.
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Req ID : 10375clinical research, clinical trials, data abstraction, regulatory compliance, IRB submissions, FDA regulations, patient scheduling, study coordination, HIPAA compliance, Good Clinical Practice
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