Definition of a Clinical Research Professional
A clinical research professional’s (CRP) practice is guided by one or more aspects of the principles of Good Clinical Practice (GCP).
CRPs may have backgrounds in nursing, pharmacy, medical technology, business administration, health record management, statistics, science, education, or other areas.
CRPs work in various settings, including private practice; cooperative research groups; public and private academic institutions; pharmaceutical, device, and biotechnology companies; Clinical Research Organizations (CROs); Site Management Organizations (SMOs); independent research and development organizations; and organizations otherwise involved in the management of clinical trials.
This definition does NOT include professionals working exclusively under Good Laboratory Practice (GLP) and/or Good Manufacturing Practice (GMP) regulations.
A CRP may function as a:
- clinical investigator
- clinical researcher
- research nurse
- data manager
- quality assurance manager
- regulatory affairs manager
- educator in clinical trial management
The duties of a CRP may include:
- data collection
- analysis, or monitoring
- case management of protocol participants
- recruitment and enrollment of human subjects
- protection of subjects and subjects’ rights
- development of informed consent documents
- preparation of adverse event experience reports
- construction or monitoring of case report forms
- maintenance of drug accountability records
- development of grants and budgets
- preparation of reports
- educating other healthcare professionals, patients or families about clinical trials
- protocol development
- program administration
- auditing research program