Throughout the course of my career, I have spent a lot of time mentoring and training CRAs, and I enjoy it. Successful protocols are but one of many aspects fundamental to successful trials, and in my experience, study specific operational documents are also essential to this process. I have extensive hands on operational experience and have created numerous key study documents in support of study compliance, such as IMP Manuals and Logs, Source Data Worksheets, Patient Diaries and Study Manuals to name but a few. When I owned and operated a small CRO I created and implemented GCP compliant SOPs and set up a clinical operation team which was fully functional.  I could help your organization to help with clinical processes as well as fill in as a temporary Senior Clinical Operations resource if needed.