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FDA Building 51 is one of the main buildings in its White Oak campus that houses the Center for Drug Evaluation and Research. The Center for Drug Evaluation and Research (CDER, pronounced "see'-der") is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act.
A clinical coder therefore requires a good knowledge of medical terminology, anatomy and physiology, a basic knowledge of clinical procedures and diseases and injuries and other conditions, medical illustrations, clinical documentation (such as medical or surgical reports and patient charts), legal and ethical aspects of health information ...
In 2002, the FDA transferred a number of biologically produced therapeutics to CDER. [8] CBER regulates a number of biologics-related products, including blood tests, computer software, and devices related to blood transfusion, which industry representatives would like to see handled by the much brisker Center for Devices and Radiological Health.
CNNMoney listed Clinical Research Associate at #4 on their list of the "Best Jobs in America" in 2012, with a median salary of $90,700. [ 10 ] The Society of Clinical Research Associates (SOCRA) is a non-profit organization that is "dedicated to the continuing education and development of clinical research professionals". [ 11 ]
"This job allows me a little more flexibility to take care of myself and my kids," she said. "I have the ability to learn, and I have that challenge - that's why it's a better fit. They push you ...
A sponsor sends a feasibility questionnaire to the local research site. The Clinical Research Coordinator completes the form on behalf of the site to determine if the local site has the patient population, support staff, medical facilities, and equipment necessary to successfully carry out the study protocol.
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