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What is a Clinical Research Associate?

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  • Written By: D. Jeffress
  • Edited By: Bronwyn Harris
  • Last Modified Date: 08 June 2018
  • Copyright Protected:
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A clinical research associate oversees medical studies and clinical drug trials to make sure that they are carried out safely and within legal guidelines. Many professionals are involved in creating protocol documents to outline research methods and explain the reasons for conducting a study. By helping to organize and supervise studies, associates ensure that statistical results are highly accurate and unbiased. A clinical research associate might work for a government oversight agency, pharmaceutical company, or private research laboratory.

Before a study can take place, the clinical research associate must work with scientists, funding sources, and governing committees to sort out the details. A professional composes a protocol document that includes information about budgets and time frames, the method of participant selection, the structure of the trial, and the potential impacts of the study. A clinical trial protocol functions somewhat like a contract in that it ensures money and resources will be available as long as researchers carry out the study correctly.

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The clinical research associate supervises every aspect of a trial, from finding participants to publishing results. He or she speaks directly with participants and researchers to ensure that everyone understands the responsibilities, risks, and legal principles involved. The associate often creates consent forms for participants and emphasizes the goal of unbiased research to the scientists. Raw data, calculations, and finished results from the study are carefully looked over by the associate to verify findings. After a study, the clinical research associate usually signs off on the protocol or creates a new legal document confirming the efficacy of the trial.

In most countries, a prospective clinical research associate is required to obtain at least a bachelor's degree in health science, biology, pharmacology, or a similar discipline. Many associates begin their careers as research assistants, helping scientists design and conduct experimental trials. Research experience is essential to understanding the scientific method and study protocols. Some countries and private industries require research associates to obtain certification by passing written exams.

With a degree, certification, and experience in the field, a hopeful associate can pursue careers in a number of different settings. Government agencies, such as the Food and Drug Administration in the United States, hire clinical research associates to oversee trials at federal or state-funded research laboratories to ensure that they comply with ethics laws. Other professionals are employed directly by pharmaceutical companies or private laboratories. Some experienced associates join college faculties to oversee research, design university policies, and teach students.

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