You are interested in the CRA profession and you want to take up this position? But do you know exactly what job you are committing? Do you know exactly what is expected from a good CRA? Do you have the level of education required to apply for this position?
First, we will describe what is a Clinical Research Associate (CRA) and in what specific area he operates. After that, we will see what qualities and skills are required to become a good CRA and what is the required training to do this job.
What does a CRA do exactly?
In the pharmaceutical sector, testing a new drug on humans is the final phase in the production of a remedy; it is the last step before the commercialization of this drug.
The CRA is in the heart of this final phase: he is the link between the department of research-development of a drug manufacturer (the promoter) and “investigators” doctors who will perform clinical studies in a hospital, a clinic or a city office. First, the CRA goes on site to assess whether the investigator is motivated by this study and if he has the technical and human resources to implement it. These doctors are finally selected by the promoter according to data reported by the CRA in his screening visit report.
The selection work done, the CRA presents the protocol to doctors and their team (clinical site coordinators, nurses, pharmacists, radiologists…), supporting documents (mode of drug administration, the tests to make or the required age for voluntary patients …) during the study implementation visit. During this phase, the clinical research associate also trains doctors and their team to clinical data reporting on case report forms (CRF or Case Report Form) and to specific procedures of the study. The CRA is also in charge of collecting the various administrative documents required for the study with the center and updating these documents throughout the study.
Apart from the selection of participating doctors to the tests and the presentation of the protocol, the CRA may also prepare submission files to regulatory authorities (ANSM, CPP, CNOM, CNIL and / or CCTIRS) at the initiation of the study and in case of changes during the study.
Finally, the CRA ensures compliance with Good Clinical Practice, the regulations and current legislation, the protocol and standard operating procedures related to the study. For this, it is necessary that the informed consent form was signed by the patient before any procedure related to the study, that the protocol is respected and that the data reported by the doctor in the CRF are consistent with the medical record of each patient who agreed to participate in the clinical study. Finally, he ensures that all serious adverse events (SAEs) have been reported to the pharmacovigilance service of laboratory within the period prescribed by law and that any new information regarding a SAE was transmitted.
All these tasks are of course supervised by a project manager.
What academic background should I have done in order to apply as CRA?
The necessary academic training to become CRA may vary depending on the employer and / or the type of drug to be tested.
You can find more information about the different specific training to the CRA profession in the article: The CRA profession training and prerequisites.
Education levels listed below allow to practice the CRA profession:
From level baccalaureate + 2
- IUDCRAT / CSC (Interuniversity Diploma in Clinical Research Assistants Training) in French: DIUFARC/TEC (Diplôme Interuniversitaire de Formation des Assistants de Recherche Clinique) – The IUDCRAT is prepared in 1 year after the second year of biology license (L2) or after a Nurse State Diploma (SD). However, it is advisable to have experience in the medical or pharmaceutical field.
Level baccalaureate + 5
Level baccalaureate + 6
- Science Ph.D. (Doctorat en science) (biology etc.)
Level baccalaureate + 8
- pharmacy State diploma of doctor
Level baccalaureate + 9 and up
- State diploma of doctor in medicine (baccalaureate + 9 to baccalaureate + 11, depending on the specialty)
However, it is noteworthy that 40% of CRAs in office are initially biologists.
- Master in Bioinformatics and Biostatistics
Basics skills are obviously a big plus: English proficiency and computer skills.
What about the qualities required to become CRA!
Apart from all the knowledge and skills acquired in one of the courses mentioned above, the CRA must also demonstrate a great rigor in order to do all the tasks assigned to him/her. A very strict organization is also one of the sine qua non imperative conditions for the CRA position.
Like any profession carried on the scientific sector, the CRA requires a great sense of ethics because it is the guarantor of good clinical practice. Of course, there is no question of the Hippocratic Oath here, but the CRA must know his/her Good Clinical Practices on the fingertips.
A CRA being made to meet different people, you will need to have high social skills: able to adapt to every interlocutor personality is a more than respectable quality when one wants to become CRA as having an acute sense of negotiation. Indeed, the CRA will have to negotiate contracts and additional hospital costs with centers. This quality is also very useful to obtain numerous documents requested to the centers on time. ;). Therefore, the CRA must absolutely learn to communicate effectively with all people he has in front of him, regardless of the nature of the latter.
Last, but not the least, a criterion that a future CRA absolutely must have is the availability. A CRA is required to travel frequently and sometimes at far distances, forcing him to stay there for the night. A flexible schedule will be required to a CRA once in office. This joins the criterion summoned above, be a good CRA requires having an acute sense of organization because conciliating private and professional life is not easy for everyone. You can find some tips about this in the article: How to succeed in reconciling personal and professional life when one is CRA
This is a preview of what awaits you, and especially the road you will have to go down to become a Clinical Research Associate. If you have questions about this profession, you can leave them in the comments of this article.
You can give your opinion or your advice for future CRAs, like you, in the comments of this article.
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