1- Most of the CRA and managers are awfully trained. Avoid asking for advice of guidance, because you will have then 2 problems instead of one: the one you went to ask for help and to calm down your manager.
2- Managers doesn’t give you a hint about how to solve the problems
3- Work overload: you will have geographical destinations, not studies. This means that it doesn’t matter the protocol, it matters where is located the site. So you could have 7-10 protocols and 15-20 sites.
4- Timelines for completing monitoring reports or number of visits required imply that you will work 7/24, during the week doing visits and completing reports on weekends, unless you apply their own CRA criteria for monitoring visits.
5- The monitoring plans are empty of content documents. They don’t give guidance about frequency of monitor visits or what is important to verify at each visit.
6- Big issues with payments to the sites. The pay system doesn’t work properly
7- Nobody seems committed to their work or to solve any problem. Solving a problem means to put a dead body in the closet or if you want a real solution, you will try to move an elephant. For example, if you find a problem with the IVRS system and you report it, probably it won’t get solved
8- It takes ages to get access to the systems (CRF, report system, IVRS, central file, and so on)
9- CRAs from the company makes SDV very shallow, so if you inherite a study from them or you have an inspection/audit it will take you hours to get the back log solved
10- If you claim that you have work overload, the answer will be that you are the problem, that the work load is ok. Let me tell you, I ended with health problems and had to resign.
