When analyzing the qualifications for a CRA position, the first factor that comes to mind is what type of clinical product is being put through trial? If a Class III product such as a new pacemaker or a cell-based infusion is being put through clinical trials, then clinical experience should definitely be a must for any CRAs that are interested. If the product however, is a Class I or II device that is not life-sustaining, then the clinical background required for such a position would likely read as “0-2 years experience”. These background requirements are put in place not only to account for a CRA’s performance in a clinical setting, but also because it’s probably what the patient prefers. Anyone who is a patient afflicted with a condition that requires clinical trials would most likely prefer to have a trained professional handle their medical needs rather than a novice. I currently work as a clinical manufacturer, where I process blood-based products for infusion. My position does not require a clinical background, though it also does not require us interacting with the patients who receive the treatments. Although patient interaction is not included in our job responsibilities, I personally believe that a clinical background should be required simply because of all of the mistakes that inexperienced manufacturers make when handling a patient’s own blood. The company I worked at prior was also a clinical manufacturing position, but it processed human skin grafts, a decellularized product that posed less risk than a product that is sent directly into the circulatory system. Since this product (called the Alloderm) was acellular, it carried little risk of transmitting diseases since it was treated with gamma radiation, so this type of CRA position would be more ideal for someone with little to no clinical experience.

Simply put, a clinical background should be associated with a position that requires the handling of a Class III device and patient interaction, otherwise for less medical-intense devices a CRA position should prefer clinical experience, but not require it. A quick search on Indeed for CRA positions shows that CRO companies such as Syntactx, requires little to no clinical experience (0-2 years preferred), just a four-year education in science. This is likely due to a CRO’s ability to place inexperienced CRAs in entry-level projects, then transitioning them to more up-scale clinical trials once they’ve acquired the necessary experience. Is it possible to work as a CRA without having to interact with patients? Should CRA experience be required for clinical trials regarding a hip implant? How much risk exactly should a clinical trial carry so that a clinical background is not required?