Good morning, everyone. This is Vanessa Montanari from the clinical research blog.
What are the developments for CRA? What are the immediate developments?
So, if you’ve been an CRA for a few years, we’re going to say from two or three years, you may want to change a little bit from monitoring and see something else. So you have different possibilities for immediate change.
So the easiest change is to move to an CRA start-up position. So there are different types of CRA start-ups. You can go towards regulatory submissions, so you can make submissions to ethics committees and the ANSM, and you can also make submissions to the NOCs. Then, you also have the possibility of being a contract CRA start-up. So, you manage contracts with hospital departments, you take care of negotiating these contracts and signing the contracts with the investigators. It’s a position that has more of a legal aspect. So those are the most immediate developments.
There is also a position that we see a little bit sometimes. It’s actually the CRA, which only deals with selection visits and feasibility. So this CRA is going to do the site selections. It will also do the feasibility. Feasibility means that it will look for centres and see if the study is feasible in the centre, if the site agrees to do the study, if it is interested. So that’s the part that is just before the selection of the centres.
There is also the CRA lead. So the CRA lead is the senior CRA, who will be asked to review the monitoring visit reports for the project leader; who will take care of certain parts of the project, for example delivery and processing management or other specific aspects of the study for which he will be responsible in support of the project leader. So, that’s another possibility as well.
So, these were the immediate evolutions, and then of course there are the longer-term evolutions which can take up to 10 years. There, you will go from project manager or you can be manager of clinical operations. As a project manager, you manage the project, and as clinical operations manager, you manage a team, we could say from an RRHH point of view: or you have annual interviews, you manage the development of people and the training of the CRA in your team.
So I hope this little video has helped you and I wish you good luck and see you soon.
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