I feel that, while not necessary, it is very advantageous to have a clinical background in the role of a CRA and especially in the role of a principal investigator. The reason for this is that a clinician has been trained to understand the day to day operations in a clinical setting, and have been directly involved in the administration of care. This is an invaluable perspective that not only brings to light the issues within the system, but also the special considerations which are not readily apparent. Of course, this can be substituted with clinical consultants or collaborators.