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Regulatory affairs (RA), is a profession that deals with an organization’s adherence to regulatory compliance.. It is a position mostly found within regulated industries, such as pharmaceuticals, medical devices, cosmetics, agrochemicals (plant protection products and fertilizers), energy, banking, telecom etc. Regulatory affairs also has a very specific meaning within the healthcare ...
A clinical research associate (CRA), also called a clinical monitor or trial monitor, is a health-care professional who performs many activities related to medical research, particularly clinical trials. Clinical research associates work in various settings, such as pharmaceutical companies, medical research institutes and government agencies.
These physicians help navigate the complex regulatory processes necessary to obtain market approval for new therapies, ensuring that trials meet stringent scientific, ethical, and safety standards. In addition to regulatory guidance, pharmaceutical physicians often lead clinical development teams, shaping the medical strategy for drug development.
Clinical documentation improvement (CDI), also known as "clinical documentation integrity", is the best practices, processes, technology, people, and joint effort between providers and billers that advocates the completeness, precision, and validity of provider documentation inherent to transaction code sets (e.g. ICD-10-CM, ICD-10-PCS, CPT, HCPCS) sanctioned by the Health Insurance ...
The Pharmacists can also choose to become a specialist in one of following areas of activity: Pharmaceutical Industry, Regulatory Affairs, Hospital Pharmacy, and Clinical Analysis. Each specialization requires an additional 5-year professional study program guided by a tutor in the respective area of knowledge.
The National Credentialing Agency for Laboratory Personnel (NCA) was a professional association for medical laboratory professionals.. It was founded 1978 by members of American Society for Clinical Laboratory Science to enable members of the medical laboratory profession to control the certification process.
A Clinical Research Coordinator (CRC) is a person responsible for conducting clinical trials using good clinical practice [1] (GCP) under the auspices of a Principal Investigator (PI). Good clinical practices principles have been defined by Madelene Ottosen, RN, MSN, of The University of Texas Health Science Center at Houston [ 2 ] as:
Clinical data management (CDM) is a critical process in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. [1] Clinical data management ensures collection, integration and availability of data at appropriate quality and cost.
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