I work at Sloan Kettering Cancer Center. We perform a lot of clinical trials. Most if-not all PIs for prospective clinical trials, have clinical experience and have been involved in other clinical trials. Some PIs have relationships with industry and perform a lot sponsored studies. I think lower level positons such a junior level monitor, junior statistician don’t have to have clinical experience but will hopefully have knowledge of good clinical practices and have gone through the proper training for these roles. The CRA should have clinical experience as well as the study coordinator or have completed the trainings as mentioned in the lecture. The CQA should have compliance experience in relation to clinical trials or proper trainingss.

On the engineering side, we usually contract work out to a company that has experience developing FDA approved devices and have knowledge of what is necessary to build a functional prototype for clinical trials. These engineers have expertise in how clinical trials are performed and what is required for a functional prototype to test.