Profession CRA sheet: My testimony at the APEC (French Association for the executives employment)
The CRA profession includes of course the studies monitoring, travel in the centers, but it also allows to do regulatory submissions and to evolve towards project management and team management…
Published: 11/26/2014 in APEC website (annuaire métier cadres)
Vanessa Montanari, Clinical Research Associate, Pharmaspecific
CRA job description: My testimony from APEC (association for the employment of executives)
In 2003, Vanessa Montanari completes her mastery of cell biology and physiology by a clinical research associate training. For three months, she learns in therapeutic areas, pathologies, and methodologies of clinical research.
« I wanted to practise a profession in which travel is frequent, where we communicate a lot with the research teams: I could not see myself in a lab to make manipulations on the bench… »
After her training, Vanessa Montanari makes two internships for a total of six months; she becomes clinical site coordinator at the Henri Mondor hospital in cardiology and then at the Institut Gustave Roussy, in oncology.
« Beside the investigator, as a clinical site coordinator, it was to identify patients who may participate in the study, complete case report forms, or assist in the organization of the study in the hospital.”
After her internships as a clinical site coordinator, Vanessa Montanari is supported in her choice of profession, but rather exercises as a clinical research associate, that is to say at the interface between the investigator and the laboratory. She wants to train the medical team, follow the studies and ensure a strict control of the proper conduct of the study. For her first position, she joined the EARO (European Association for Research in Oncology) which is a promoting organization of clinical trials.
« This association was looking for someone who had been clinical site coordinator, who had experience in oncology: my profile was therefore appropriate. For a year and a half, I made the monitoring of studies launched by this cooperative group, in partnership with laboratories that provided the molecules. »
Her desire to work abroad and master her English drove Vanessa Montanari to apply within a CRO [1], PPD. She has the opportunity to work there on projects in oncology, but also about HIV or in hematology. The tests are conducted abroad, and Vanessa Montanari communicates exclusively in English with the clinical project manager and the laboratory: « daily, as part of the monitoring tasks of the CRA [2], I was in contact with the investigator, clinical research nurses, medical secretaries, hospital pharmacists, clinical site coordinators…and even with the hospital management for the contract management. »
With experiences, Vanessa Montanari is entrusted with new responsibilities: « as an experienced CRA, I was brought to work on the regulatory submissions. To begin a survey, you must request authorization from the ethics committee and the ANSM[3], or with the CNIL[4] and CCTIRS[5] depending on the type of study: so we must prepare records, collect the necessary documents and maintain relationships with these authorities. »
Wishing to discover new world of work, Vanessa Montanari is recruited by another CRO that enables HER to be detached within a pharmaceutical laboratory. For a year and a half, she is CRA within Abbott laboratory and collaborates in clinical studies while developing her relations with the departments of communication, marketing, sales, regulatory affairs, pharmacovigilance…: her knowledge of CRA profession is completed. She therefore launched in 2010 as a freelance CRA and creates her company, Pharmaspecific: « I wanted to choose my assignments, communicate directly with my clients and work on some therapeutic areas in particular. » Working with French or foreign CROs as well as pharmaceutical companies, Vanessa Montanari is now an entrepreneur and manages a small team of CRA.
[1] Contract research organization [2] Clinical Research Associate [3] National Security Agency drug [4] National Commission on Informatics and Liberties [5] Advisory Committee on the treatment of research in information in the field of healthIf you liked this article, I invite you to like or share with your colleagues and friends clinical research associates and project managers. You can go on the Facebook page of « clinical research blog » and « Pharmaspecific » and click on « Like » to support us. You also can subscribe to the blog’s newsletter; we will inform you of new articles as soon as they are posted.{:}
