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We held a question and answer session on Christmas at which all questions were allowed.

In this podcast, I answer questions from Rosita, Lisa, Nathalie and Mariama about the CRA profession.

Good listening to all.

Rosita,

First I wish you my best wishes for this year and full of success for your company. I am originally a graduated CRA nurse since 2015 with a small experience of 2 months on an epidemiological study at the INSA. Wanting to work in homebased or freelance, where and how to offer my services or contact other freelancers to share my info and advice?

I find it a little premature to become freelancer after 2 months of experiments on an epidemiological study. The best thing is that you have more experience on clinical studies. Alternatively, you can also work as a clinical research nurse. There are companies looking for clinical research nurses or CSCs. In particular, you can visit the AFCRO website where you will find the names of some companies that are looking for CSCs. To share information with freelancers, if you type CRA freelance on the web, you will find associations of CRA freelance. There are 2 associations. So I let you do your research on this.

Lisa,

Hello Vanessa, I have been project manager in logistics for clinical trials for 2 years. I do secondary packaging and labeling batches for clinical trial and project management and coordination with monitoring clinical trials. I would like to evolve as clinical project manager. What do you think? Do I have enough experience to be able to work in this position?

I see that you are project manager in logistics, you have been monitoring clinical trials for 2 years and project management. If you have done monitoring well, your profile could interest companies of medium size, small companies, so you can try. Do you have enough experience? 2 years seems a bit fair but you never know. You can also head to medical device companies that may need people who have done monitoring, who have done project management to manage their observational trials or clinical trials.

Nathalie,

Hello, I am a medical delegate for 19 years and I made a CSC FARC IUD 6 years ago. I was not able to continue the practice, being engaged in my position as a delegate. Today it is time for me to reconvert myself, but I have to get back to the agenda with practice. In your opinion what would be the training in Paris, the most interesting in this case: Clinac, Sup Health, Leonardo da Vinci, and CURC

You already had a CRA training 6 years ago, I think you could try at first, if you did not have, to apply for company to see if you can find a position either in the hospital, in small CROs, to see if you can find a job. If you do not find it, you can try to do a training again, but I think it’s a shame to have to do a training while you already have one and for the most interesting training for me, I think it is Sup Health. The others are very good also, these are formations that are different but they are all very well. It seems to me that the DUARCO IUD is specialized in oncology, that is, that really said I’m not convinced that to do a training is interesting and I think you will have to think about all this because, well you continued as Delegate, why did you do this IUD if in the end you did not practice directly because I think that your objective was to become CRA and no longer remain delegate, then I think you should dig a bit more deeply, why you are there today.

Mariama,

First of all, I would like to wish you a happy new year 2017. Currently I am enrolled in a CSC training course in Créteil, soon I start my internship to validate my diploma. My question was therefore to know what skills and knowledge to acquire to the maximum during the internship, to better begin my career in clinical research. Are there possibilities to switch from CSC to CRA monitor? Thank you in advance for your answers.

The knowledge you must acquire: you have to learn to translate a medical record, because it is not necessarily something insignificant, something that you may not have seen in the past, so you really need to understand how a medical record works, how it’s written, understand the writing of doctors, and also understand the hospital environment. Then you have to learn how to extract the information from the medical file and put it in a case report form.

What is also good is to be able to practice any type of visit, monitoring, screening to closing notice visit, to see and interact with CRAs, from the promoter, to see the types of requests that they do, to learn to communicate with them, and interact with CRAs, doctors, with your CSC colleagues, then what will be interesting is that you know well, how investigator workbooks work, the documents that are needed in these workbooks, and then ultimately you learn to organize clinical research in a hospital department. Interact with the various stakeholders in the study and ensure that all these stakeholders allow the clinical study to be conducted in accordance with good clinical practice. The reporting of a SAE, what to do in case of problems, an investigator who is not there. Also informed consent, really all the notions we talk about in GCPs, that is the knowledge that you have to learn and that you will be able to put forward in your resume.

So, I finished with the Christmas questions-answers, I’m really sorry, maybe I gave you them a little bit late. Unfortunately with my different activities, I could not do otherwise, I try to do my best to answer you, and I hope you had the answers you expected. I wish you continued success in your activities and all the success you deserve. See you soon and consider registering on the clinical research blog and on our YouTube channel to get all the articles and benefit from all our video tips.

See you all, and thank you again. Goodbye!

Si tu as aimé cet article, je te remercie de « liker » ou de partager avec tes collègues et amis Attaché de Recherche Clinique :)

5 Comments

  • Sarah dit :

    Bonjour Vanessa,
    Je suis diplomée d’un doctorat en immunologie et j’ai effectué un post-doctorat aux USA l’année dernière. Je voudrais m’orienter vers le métier de MSL mais n’ayant aucune expérience dans l’industrie pharmaceutique, je n’ai reçu que des refus. Je n’ai donc pas trouvé d’autres solutions que de suivre une formation d’ARC pour avoir un pied dans l’industrie et pouvoir par la suite évoluer en tant que MSL. A la fin de cette formation je dois faire un stage. Au début je voulais faire ce stage d’ARC directement dans les CRO mais en entendant des professionnels parlés autour de moi, ils me suggèrent d’avoir une expérience en tant que TEC afin d’être un meilleur ARC. Je ne sais donc plus quoi faire, j’hésite à effectuer ce stage dans une URC (et donc partie investigateur) afin d’acquérir plus d’expérience sur le terrain et ensuite me diriger vers les CRO ou bien effectuer un stage en tant qu’ARC moniteur dans un hôpital. Que me conseillez-vous? Est-ce bien utile de passer par cette étape en sachant très bien que mon objectif est de travailler dans l’industrie pharmaceutique? En vous remerciant par avance pour votre aide.
    Cordialement,
    Sarah

    • Vanessa Montanari dit :

      Bonjour Sarah,

      Je ne suis pas spécialiste du métier de MSL. Je dirai qu’il vaut mieux faire un stage de TEC pour connaitre le milieu des investigateurs. Cependant, je te recommande de contacter des MSL sur LinkedIn afin qu’il te donne des conseils.

      Bon courage,

      Vanessa

  • Anonyme dit :

    Bonjour, je suis pharmacienne et j’ai déjà de l’expérience dans le domaine des essais cliniques et des affaires réglementaires dans l’industrie pharmaceutique. J’ai quitté la métropole pendant quelques années pour un département dans les DOM et de retour, je suis maintenant à la recherche d’un poste qui me permettrait d’utiliser cette double compétence. Je suis actuellement une formation sur internet pour réactualiser mes connaissances dans les essais cliniques. A quel type de poste puis-je prétendre ? Pour des raisons familiales, je me pose aussi la question du « home office » et/ou télétravail (au moins partiellement) et j’aurais aimé en savoir un peu plus à ce sujet.

    Merci d’avance pour votre réponse.
    Cordialement
    Laurence

    • Vanessa Montanari dit :

      Bonjour,

      Tu peux travailler en tant qu’ARC ou au service des affaires réglementaires (soumission ANSM, CPP …) en tant que sédentaire. En général, les postes « home-based » sont attribués à des personnes ayant déjà eu cette même expérience. Il faut poser la question dans tes prochains entretiens. C’est devenu assez courant dans les CRO globales (type PPD, Covance…).
      A mon avis, il faudra tout de même travailler en « office-based » avant pour montrer…

      Voilà

      Vanessa

  • Vanessa Montanari dit :

    Imen,

    Je ne peux pas me prononcer que des formations dont je ne connais pas le contenu en détails et que je ne connais pas bien. Le mieux est de contacter des personnes ayant fait ces formations et de regarder sur LinkedIn « que sont devenus les personnes ayant fait ces formations? ». Il vous suffit de taper le nom de ces DU dans la barre de recherche de LinkedIn ou viadeo.

    A bientôt,

    Vanessa

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