The Clinical Research Associate I supports the coordination and implementation of clinical studies by working closely with clinical research staff. They manage data abstraction, case report forms, patient scheduling, regulatory submissions, and ensure compliance with federal and institutional guidelines. This role provides valuable experience in clinical research processes, regulatory adherence, and patient interaction within a health equity research setting.
Job DescriptionThe 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.
The value of this experience with the Tan Lab would be invaluable for the right candidate interested in pursuing advanced training and/or doctoral degree in health equity research and/or community-engaged research methods. The candidate will have the opportunity to actively engage in all aspects of the research lifecycle—from research design through dissemination.
Primary Duties and Responsibilities
Requirements:
Preferred:
clinical research, data abstraction, regulatory compliance, case report forms, patient scheduling, IRB submissions, FDA regulations, Good Clinical Practice, health equity research, clinical trial management
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