Today, I am in Guadeloupe, at the Pointe des Chateaux. In the distance, you can see the Désirade. It’s a great view so I wanted to make this video here to answer the questions of Fabrice and Abi. The sea is a bit hectic but pretty.

 Fabrice

I started the CRA profession 20 years ago and stopped it 10 years ago. During this period, monitoring consisted of making an appointment with the investigator, comparing the medical file with the case report form, making the investigator to correct in person any inconsistencies and taking the duplicated sheets from the case report form. There were other tasks of course, but that is not the purpose of my question.

How is the monitoring today with the highly use of the electronic case report form?

Thank you.

Today there is a lot of « remote monitoring« , the CRA will regularly contact the CSC and the latter will fill in the case report form. The investigator returns the case report form and sign it mainly.

There are many things that will happen remotely, the queries will be done remotely. And the CRA will be able to verify that the CRF is correctly filled and better assist the CSC in filling the CRF. This saves time for monitoring video and has better monitoring videos because they are better prepared.

Abi

I have 3 year-experience of CSC in oncology, in national and international hospitals. I have a good level of English but a weak experience in monitoring. I want to go private, I do not want to travel so it is difficult to find a CRA position unless it is possible to negotiate only regional travel. CRA in house would be ideal, but I do not see any offer at this time. CTA I think it will be below my experience and also paid less but, if no choice, I can consider.

« Study start-up specialist », what is it? Would that be suitable for me? Can you give me your opinion on the points I have made?

CRA in house is a CRA that can be led to do remote monitoring, to recover documents from the center, so it is a CRA that does not move. This is a position that would be interesting for you as you do not want to move. Perhaps at this moment there is not necessarily an offer but do not hesitate to make spontaneous applications with laboratories and CROs. CROs have mostly this type of in-house position.

There are CROs like PPD, PRA that really have this type of in-house position. For study start-up specialist, it is a CRA that makes regulatory submissions to the CNOM, the CCTIRS, the CNIL although there are some things that will change with respect to the CCTIRS; As well as to ANSM and the CPP.

In general, to make these submissions, CROs and the pharmaceutical laboratories search for experienced people so if you have little experience you will have difficulties to find a position in this field. I think the best for you is to be like CRA in house because the CTA position is an assistant position. In terms of salary, salaries are equivalent to those of CSCs in the hospital, so it is not in terms of salary but in terms of using your knowledge in clinical research.