Clinical Research Associate Training Information
A clinical research associate assists with clinical trials of new pharmaceuticals, medical devices or treatment methodologies. Associates come from varied backgrounds, with degrees in such diverse subjects as business administration, statistics and teaching, but generally have a degree in one of the life sciences.
Training Information for Clinical Research Associates
The training of clinical research associates used to be handled on site and on-the-job under the supervision of the physician or scientist leading a clinical study. Certificate and associate's degree programs have since emerged to bring some consistency to the skill set of associates. Program courses may include data collection, management and reporting, clinical research terminology, federal laws and regulations, research protocols, research site management and professional ethics. Students may also participate in actual research studies through supervised fieldwork courses.
Duties and Skills
Clinical research associates perform a number of duties and learn varied skills during training. These may include preparing a test area, setting up and breaking down equipment, recruiting and enrolling test subjects in clinical trials, and explaining testing procedures to subjects. Clinical research associates may also administer experimental medications, monitor and record the responses of subjects, write progress reports, and interact with institutional review boards and government inspectors to assure compliance with regulations.
While the federal government does regulate clinical trials, as yet there is no official requirement that clinical research associates must be certified to work. Nevertheless, two professional organizations have established standards for those who are working in this field. The Society of Clinical Research Associates (www.socra.org) has developed an examination that certifies the competence of its members as research associates. The Association of Clinical Research Professionals (www.acrp.org) also offers an exam, and requires members to renew their certification every two years as well. To maintain their certification, association members must earn continuing education credits in addition to passing the recertification exam.
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