How to be training, find a job and practice clinical research associate job
Jacques
Salut Vanessa,
Je voudrais te dire sincèrement merci pour ce blog car il nous aide beaucoup, surtout nous qui réorientions nos carrières. Recommandé par un ami, il est ma source d’information de première intention. Je comprends mieux et progressivement le métier de recherche clinique. J’ai hâte de lire les conclusions de ton projet en cours. Continues de nous aider, que Dieu te bénisse et te rende au centuple.
Cordialement,
Jacques, 37 ans
Médecin généraliste
Haoling
Salut Vanessa,
Merci pour ce blog qui m’a aidé de connaître le métier d’ARC : les formations à suivre, tous les infos très utiles pour comment devenir un ARC, etc. Avec votre blog, je suis très motivée de me reconvertir en recherche clinique!
Haoling, 30 ans
Demandeur d'emploi, Rennes
Davy
Je trouve que ce blog est extrêmement pratique et instructif. Il regorge d’informations essentielles pour toutes personnes souhaitant entreprendre une carrière dans le domaine de la recherche clinique. Merci pour ce travail quotidien et pour votre temps personnel que vous mettez au service des autres. Je suis admiratif.
Davy, 30 ans
Chimiste médicinal en reconversion, Québec
Nadia
Mille fois merci Vanessa. J’ai découvert ton blog juste au moment où je cherchais des informations sur comment embrasser ce métier. Ceci n’a fait que me renforcer dans ma motivation. Et là je suis fixée vers ce seul but. Je n’hésite plus. Je suis impatiente de commencer cette formation.
Nadia, 37 ans
Cotonou-Bénin
Aude
Merci pour cette initiative car le monde de la recherche clinique reste fermée et cloisonnée (public/privé).
Aude, 47 ans
En recherche d'emploi, Rhône-Alpes.
Viviane
J’ai pu approfondir mes connaissances sur le métier, ses exigeances, … pour ainsi mieux me préparer à changer de métier
Viviane, 37 ans
Technicienne de labo, Lyon
Saran
Bonjour Vanessa, vraiment merci beaucoup pour ce blog il est magnifique et très bien explicité, il m’a beaucoup aidé à choisir entre le métier de TEC et ARC et aussi lors de la préparation de mes examens.
Saran, 27 ans
En recherche de premier emploi, Marseille
Audrey
A chaque fois que je recherche un réponse à l’une de mes questions sur les essais cliniques, la réponse se retrouve très souvent sur votre site. Donc il est plutôt complet !
Audrey, 27 ans
Strasbourg
Salima
Ton blog est très bien fait. En lisant ton expérience personnelle je me suis trouvée des points communs avec toi. Parcours du combattant pour y arriver. je veux devenir ARC cela fait déjà quelques années. Ton blog m’a donné encore plus convaincu pour exercer ce beau métier. Merci Vanessa.
Salima, 39 ans
Lyon
Aurélien
Blog très bien fait et très informatif, avec des réponses rapides et claires au questions posées. Juste un mot : bravo !
Aurélien, 28 ans
Vitry-sur-seine
Khadija
Chère Vanessa, je te renouvelle mon entière satisfaction pour ton blog et pour ton partage d’expériences toujours très utiles. Les sujets sont variés et couvrent une bonne partie des activités quotidiennes. Ce blog n’a pas d’égal et c’est tout à ton honneur que de l’avoir crée et de le faire vivre continuellement afin d’aider les professionnels de la recherche clinique à progresser sur différents sujets. Merci mille fois pour tous ces sujets tous très intéressants et j’espère que le blog continuera à s’enrichir avec de nouveaux thèmes et qu’il puisse répondre aux problèmes qu’on rencontre chaque jour dans les projets. Je t’admire pour cette très belle initiative et te souhaite une très belle réussite dans ta belle entreprise (professionnelle et humaine, ce qui est rare!)
Khadija
Hauts de Seine
Thibault
Bonjour à vous,
Tout d’abord merci pour votre blog ! Il m’a motivé il y a quelques années à me lancer vers le métier d’ARC. Je venais alors d’échouer à l’accès à la formation du métier dont je rêvais petit. Vous avez contribué à ma réorientation professionnelle et j’ai pu apprendre de vos conseils pour finir mes études, passer le DIU FARC TEC, et finalement trouver un apprentissage en tant qu’ARC promoteur en cancérologie. Merci pour tout, et continuez à aider notre belle famille d’ARC !
Thibault, 24 ans
Paris
Julia
Votre blog et merveilleux et constitue une mine d’informations qui m’est très utile. J’arrive mieux à cerner mes objectifs professionnels et les nombreux conseils prodigués me rassurent et m’aide à progresser dans mon travail. Je vous remercie donc pour le temps que vous y consacrez !
Julia, 23 ans
Stagiaire ARC, Lyon
Elodie
Le blog est génial c’est tellement rare de trouver des informations sur notre métier
Elodie, 28 ans
Angers
Zahia
Merci beaucoup Vanessa pour ton blog. Je me rend régulièrement car c’est très enrichissant et on apprend toujours des choses avec toi.
Zahia, 39 ans
Courtry
Laura
Vous faites vraiment un beau travail, une chose à dire pour résumer : Bravo. Et merci! Du coup cela fait deux!
Laura, 27 ans
Paris
Alexandra
Bonjour Vanessa, je suis admirative de la qualité du blog et que tu puisse gérer tout ça en même tant que ton activité de chef de projet/ARC c’est épatant!
Alexandra, 35 ans
Les Ulis (91)
Achraf
Salut Vanessa, ton blog est super intéressant et il m’a apporté personnellement du soutien psychologique, continuez comme ça vous êtes sublime et vous mettez beaucoup d’énergie positive autour de vous.
Achraf, 33 ans
Marcoussis
Sarah
Merci beaucoup pour ton implication pour nous faire découvrir toutes les facettes de la recherche clinique!
Sarah, 29 ans
Paris
Mamadou
Bonjour, je suis régulièrement vos posts sur les réseaux sociaux et professionnels. Je suis aussi abonné à votre blog. C’est l’un des sites les plus complets pour connaître et évoluer dans le milieu de la recherche clinique. Merci aussi pour votre proximité aux abonnées en répondant à leurs questions de façon personnalisée. Merci
Mamadou, 29 ans
Jeune diplômé à Paris
Liliane
Salut Vanessa, j’adore ton blog il me permet d’accéder à des informations pertinentes et je trouve dommage de ne pouvoir y contribuer financièrement. J’espere que cette initiative ira encore plus loin à l’avenir car très utile!
Liliane, 27ans
Dr en chirurgie dentaire, Toulouse
Tinhinane
Merci pour ce magnifique blog.
Tinhinane, 25 ans
Stagiaire à Paris
Sandra
Chère Vanessa,
Merci beaucoup de tant investissement dans le blog de la recherche clinique.
Les informations qui y sont présentées me sont très utiles pour faire évoluer mon projet de carrière (mon objectif est de devenir ARC après avoir travaillé 15 ans dans le monde de la recherche académique). Un grand merci!
Sandra, 37 ans
Postdoctorant, Louvain (Belgique)
Kelly
Bonjour Vanessa ! Ce blog est extrêmement bien fait et très précieux pour y retrouver une multitude d’informations et de conseils. Il nous permet de voir que tout est possible avec de la volonté ! Merci beaucoup pour ce travail accompli afin d’aider de nombreux acteurs de la recherche clinique! Kelly, 28 ans, Paris
Kelly, 28 ans
Paris 12ème
Inès
Bravo et Merci pour les conseils et l’aide que vous apportez aux débutants dans le métier. Ce n’est pas toujours claire la difference TEC/ARC et toutes les autres terminologies et vous rendez ça plus simple
Inès, de Lille, 20 ans
Étudiante à l'ILIS en licence Science pour la santé option rechercher clinique
Alessandra
Je vous remercie pour votre blog, plein de conseils et bonnes adresses! je connaissais très peu de ce métier et vous avez ouvert un monde!
Alessandra, 38 ans
Paris
Eléonore
J’aime beaucoup les détails précis sur la description des activités ARC. Par exemple : sur une visite de monitoring, la description de toutes les tâches à faire, les outils à utiliser, astuces etc… Cela est précis et donne l’impression d’accompagner un ARC pendant une visite, de l’observer, ce ne sont pas que des généralités comme dans un cours. Un grand merci pour cela car cela m’a beaucoup aidé lors de mes débuts !
Eléonore 29 ans
ARC, ILE DE FRANCE
Etson
J’apprécie le travail qui a été réalisé pour rendre ce métier moins obscur.
Etson, 31ans
Vitry sur Seine
Abir
Bonjour Vanessa, tu es une génie dans tout ce que tu proposes : des articles , livres, conseils. Je t’encourage du fond du cœur et je te souhaite plein de succès
Abir, 33 ans
Marcoussis
Séphora
En tant qu’ ARC, les articles sur le monitoring (pharmacie, consentement) m’ont beaucoup aidée. Votre blog est super et très utile.
Séphora
32 ans, ARC, Dakar (Sénégal)
Hadiza
Bonjour Vanessa. j’apprécie vraiment ton Blog et je lis régulièrement tous tes newsletters. Cela m’aide énormément dans mon poste actuel, et me motive à continuer dans la recherche. Je te souhaite bon vent!
Hadiza, 27 ans
Bobo-Dioulasso (burkina-Faso)
Angélique
Merci pour toutes ces informations elles m’ont aidé dans mes choix et dans les entretiens
Angélique, 26 ans
Nice
Morane
Une belle initiative qui remotive les troupes : une source d’inspiration !
Morane
26 ans, TEC, Nantes
Sophie
Merci pour vos conseils, c’est toujours très profitable !
Sophie, 28 ans
TEC coordinateur, Marseille
Hakim
Depuis que j’ai découvert ton blog je suis devenu FAN!!! Il est très bien constitué et très explicite! C’est ce blog qui m’a convaincu que j’étais fait pour le métier d’attaché de recherche clinique! Tu éveilles les passions…Vraiment BRAVO!
Dans notre pratique quotidienne, nous sommes confrontés à tout un tas de textes législatifs ou règlementaires : lois, règlements, directives, arrêtés, décrets… Pourtant, il peut parfois être compliqué de s’y retrouver tant ces textes sont nombreux.
Pharmaspecific vous propose donc, dans cet article, de mieux comprendre comment s’organisent ces textes et comment les comprendre.
Informed Consent Forms (ICF) and Patient infrormation Sheet: 10 Tips to acheive your goals
If you need to prepare an informed consent for for an ethic committee in France, contact us www.pharmaspecific.com
Transcription : Hello everyone, this is Vanessa Montanari from the clinical research blog for Pharmaspecific.
Today, we will talk about consent and the information note I will give you 10 tips to succeed. But first of all, I would like to tell you that through Pharmaspecific training, we have created kits so that you can carry out your consents and information notes in a serene manner.
So, what will you find in these kits? You will find consent models for all types of situations: emergency situations for children, classic situations for an adult … you will have several types and many more besides. Several types of situations. Next, you will find a guide in which we will explain how to write your consent. Paragraphs, examples of sentences to put in your consent, the regulatory texts that must be in your consent and in your information note. You will not find this kit anywhere else, at least not in the French-speaking world. So, now, I am going to give you the 10 tips to make your consent and your information note a success. First of all, at the level of the police. The font must be easily decipherable and that’s why it must be at least size 12. If it’s about elderly people, you can even go up to 14, that’s my first piece of advice.
My second piece of advice is that the terms used should be simple. If you have technical terms and abbreviations, you should explain everything the first time you use them. The consent and the information note must be clear to the patient.
Third, the letter must be adapted to the category of people you are addressing. If you are writing to a 6-year-old child, you will not be able to speak and write in the same way as a 15-year-old child, or a parent of a child, or an elderly person. So you will have to adapt.
The fourth point is language. It must not be anxiety-provoking. It is preferable that you use the conditional and the subjunctive when you talk about anything that is risky for the patient.
Fifth, the consent form and the information note should be paginated so that the person who is going to open the consent form and the information note will need to know how many pages you have. Therefore, located on the first page of 15 pages, it should be marked 1 out of 15. You must also put the name of the study, the version number, the date of writing of this consent template and the terms informed consent form; if it is an informed consent form; or briefing note; if it is a briefing note. You must indicate this in the footer. Be aware that these documents can be separated. You can either separate them and then paginate them differently, or you can combine them into one document. Then it will be as the footer title of the Informed Consent Form and Briefing Note.
Sixth, you can ask the patient to initial, but it is not always mandatory. Be aware that some Ethic committee in France s ask for it, some require it and some will refuse. You can find this type of information in our kit.
Seventh point, avoid certain formulations that could embarrass the patient. For example, we don’t say if you get pregnant. This word has a negative connotation that is not well perceived in a consent. It is better to use a term such as if you are pregnant. You should also avoid words that refer to a sensation, a feeling. I’ll give you an example. In a sentence such as a needle will be gently inserted into your arm. In reality, you don’t know if the person who is going to take the sample will really be delicate and delicacy is something subjective. So some patients will be in pain, others will not. So you have to avoid all these words of sensation in the informed consent and in the information note.
Eighth point, at the level of the information note. Since it is intended for patients, it is the study physician who addresses the patient. It should be written in the second person. The consent form, on the other hand, is the patient’s attestation. The patient agrees to participate in the study. Therefore, it must be written in the first person. “I understand that …”. So, you should know that to help you write this consent, you can find in the MR001, sample sentences to help you write your consent. The MR001 is the CNIL’s commitment to compliance. It is therefore a document that can also help you.
Tenth piece of advice, make sure you reread your protocol and your observation notebook before reviewing your consent. Make sure that each examination performed is described and that the patient is informed of all the risks. You can also use the Investigator’s Brochure. So, in general, the informed consent form and the training note are written in French. It is mandatory that they be written in French. Sometimes, when you are in an international study, you will receive documents in English. These documents will be translated and you will adapt them to French regulations and to the expectations of the French Ethic committees.
That’s it, so I’m finished for his little advice. I hope that they will help you to write your consent and your information note. See you soon!
Transcription : Hello everyone, this is Vanessa Montanari from the clinical research blog. Today we are going to talk about a new subject. Which job in clinical research is the most suitable for a doctor of biology?
So, there are currently two purely clinical research professions that I would say are the most suitable for a doctor of biology, and another profession that is a little bit on the borderline of clinical research, which I’m going to tell you about, which could also be adapted to a doctor of biology.
So first of all, there is the job of Clinical research associate, and therefore the job of quality controller. So the doctor of biology is going to use his biological knowledge and all his rigor to be able to carry out controls in the context of clinical studies.
He can also become a project manager in some countries and also in some… for example in a hospital, he can no longer easily access this type of position, which is the position of project manager.
Afterwards, for the doctor in biology who likes the bench, he will be very disappointed by the job of CRA since it is a job where there is no bench at all but only paperwork. So you really have to be aware of that.
Then there’s the job of medical writer. So as a medical writer, you have to write consents, investigator brochures, protocols, articles. So it’s a writing job. The doctor of biology will use a good part of his knowledge, of what he learned during his doctorate, and if he has done a post-doc it will help him a lot. So I think that the job of medical writer is one of the most suitable because the doctor of biology will really use some of what he did in his doctorate and post-doc.
Then there is another job that can be interesting for a doctor of biology. You have to know that it is a job where this type of profile is favorized. The profiles of doctor of biology or post-doc. This is the job of MSL. So it’s Medical Scientific Liaison. So, these are professionals who are in charge of being in contact with medical doctors. But for all the scientific aspects of the products, if the medical doctors have questions about the products, if the doctors want to carry out projects such as clinical studies as a sponsor, then they are in contact with these MSLs and the MSLs help them to set up their clinical studies. So, it is not a job of clinical research, but it is a job that is very close to clinical research.
So, there are these three professions that I think are more adapted and according to what the doctor of biology appreciates. If he appreciates doing control and working on something very administrative, he will choose the CRA profession or the project leader profession. If he has a preference for writing, for the scientific aspect in the sense of document writing, writing articles, research, etc., bibliographical, then he will be more of a medical writer. If he has a penchant for relating to medical doctors, reporting scientific information, setting up projects with them, then he will be earlier on the MSL professions.
So, thank you for following me and I’ll see you very soon.
The earthquake: Invalidating the Privacy Shield and clinical research (Now, what?)
If you need a service of a lawyer in France for better understand the french law contact us www.pharmaspecific.com
Transcription : Hello everyone, this is Manon Durand, health lawyer with Pharmaspecific. Today, we are going to talk about the protection of personal data through the invalidation of the privacy shield. Since you couldn’t miss this information, the privacy shield has recently been invalidated by the Court of Justice of the European Union. Before starting, I would like to remind you that you can find all our legal information on our Pharmaspecific training website to keep you informed of the latest news in the field of clinical research. If you have a question of legal order, you can also ask me about it on the same platform to get an answer. So let’s start right away on the topic of the day.
As a reminder, the privacy shield was agreed in the field of personal data protection law negotiated between 2015 and 2016 between the European Union on the one hand, and the United States of America on the other hand. The privacy shield consisted of a series of provisions that regulated the protection of personal data that was transferred from a member state of the union to the United States, which in fact made it possible to transfer data without having to resort to the various protection mechanisms that are provided for today by the GDPR. In particular, the standard contractual clauses, binding corporates rooms etc…
The privacy shield had itself been put in place following the invalidation of the safe harbor by the European Court of Justice, which in October 2015 issued a first decision in which it considered that the safe harbor did not provide an adequate level of protection. Following this decision, the privacy shield was put in place to compensate for the failings of the safe harbor by adding additional guarantees for the individuals concerned. However, in a ruling handed down on July 16, 2020, the Court of Justice ruled that the privacy shield mechanism also did not make it possible to compensate for the limitations of U.S. law. According to the Court, the privacy shield system was not sufficiently independent from the US executive branch since US public authorities can access and use personal data transferred from the European Union. All this actually stems from the fact that the Cloud Act was passed in 2018, which is a law that in fact gives US companies full legitimacy to transfer their customers’ data independently of their hosting territory to any US judge who would request it without the owner or the country of residence or the country storing the data being informed. The Court of Justice considers that such access and use by the U.S. authorities therefore does not meet requirements equivalent to those expected under European Union law by what is known as the principle of proportionality, since surveillance programs based on U.S. regulations are not limited to what is strictly necessary. Therefore, since the privacy shield system does not ensure an adequate level of protection, the adequacy decision rendered in 2016 was then overturned by the Court of Justice and the transfers of personal data can therefore no longer be made freely to organizations located on US soil, even if they are members of the privacy shield.
So, if you need to transfer personal data to a company located on U.S. soil, you must have sufficient guarantees, particularly with the help of the various tools put in place by the RGPD. As a clinical project manager, several verifications must therefore be made. First, it is necessary for you to make an assessment of the personal data that may fall under this scenario, particularly in cases where you use tools hosted in the United States. You must also be vigilant on this point because even large platforms like Microsoft are concerned by these new rules. You should therefore find out about the measures adopted by the hosters of all your work tools and check whether their personal data protection policies are adapted to the requirements of the RGPD and, if not, turn to European solutions. Then, if you are in connection with a clinical study whose sponsor is located in the United States, you must ensure that no transfer of data that will be collected in the European Union, such as patient data contained in the case report forms for example, is made to the United States without having put in place standard contractual clauses with this sponsor. These contractual clauses should be very precise on the measures adopted to guarantee the security of the transfer and I strongly recommend that you put in place an encryption solution for such transfers. You also have the site of the CNIL which proposes model contract clauses that can be used as a basis for setting up this tool. Finally, you should contact the DPO of your company in order to modify the different documents required by the CNIL. For example, processing records and impact analyses to bring them into line with the new measures you will have adopted.
That’s it, you are now informed of the reasons for the invalidation of the privacy shield and the consequences for your company and your clinical study. For any additional information, please do not hesitate to refer to our legal watch or to contact me to seek legal advice.
Thank you for listening to this podcast and feel free to share it with those who might be interested in this topic. As for us, we’ll see you soon for a new podcast.