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I have been working at Premier Research full-time (more than 5 years)Pros
It is nice to be able to use Word for monitoring reports, as opposed to using a web-based CTMS. Reports are easier to write in Word. Pay for Sr. CRA is good. Clinical indications are new and interesting. My line manager has been great.Cons
Many sponsors for these novel studies have not run studies before, and they need guidance from experienced CRO staff. CMs here seem to be completely over their heads for whatever reason. No monitoring experience or no managing experience, perhaps. A lot of the traveling CRA staff are far more experienced in running trials than the CMs seem to be. Some CRAs seem to be over-utilized severely. Training is disorganized, paper-heavy, and inefficiently tracked. Every SOP does not require annual review. Home website for employees is a mess- its hard to find what you need.Advice to ManagementAdvice
Be FAR more involved with study preparation. 99% of the issues that I have seen on studies occur when source docs or protocol plan is not properly vetted and reviewed by experienced team members, and input isnot considered and acted upon. Many time-consuming and expensive problems are caused down the line when source data collection tools and methodology are inadequate. This is an easy fix, people. Prep studies better before you consider them started. Also, get the CRAs who will be monitoring the sites to do the SQVs and the SIVs. They won't allow a mess to go through if they know they will have to clean it up themselves.
Ensure that CMs are providing useful and relevant info to study teams on a routine basis. There are not enough study updates on some of these trials. Use a template and make it easy for them.
Again, over-utilization of some staff is killing you by causing turnover. Get this under control fast. 2 DOS a week is plenty if the problems at each site (due to poor study design) are huge. IN the short term, you have to make your CRAs willing to put up with the sub-standard study designs.RecommendsNeutral OutlookNo opinion of CEO