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What EXACTLY does a CRA do?

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What EXACTLY does a CRA do?

Postby Jessie » Wed Nov 03, 2004 7:54 pm

I keep getting caught up on this industry jargon, such as whatever a CRA is. I told one of my network contacts that I was interested in the clinical research area, and that person said that I ought to consider a CRA position. I'm vaguely familiar with that --- but what does a CRA do?

Jessie
Jessie
 

What EXACTLY does a CRA do?

Postby John J » Wed Nov 03, 2004 10:41 pm

Without going into too much detail - a CRA (clinical research associate) looks after the day to day running of a clinical trial. They sit below the clinical project manager (or senior CRA depending on the size of the study or company) and above the CTA (clinical trials assistant) in the pecking order. The role involves a lot of paperwork!!! They can be involved from set up phase where trial protocols are developed and ethics committee submissions are made, through to the execution phase where trial sites are brought on board and patient records (CRF's - case record forms) are completed and checked. This stage involves a lot of travel to sites and working closely with site clinical research nurses and data monitors. Then as the study closes they get involved in winding up sites and ensuring all CRF's are complete and accounted for etc. It's a great way to learn about the medical side of the biotech / pharmaceutical industry. Lot's of CRAs go on to roles in regulatory affairs, medical marketing, medical information and field based technical positions. If you enjoy following process and are very very detail oriented then you'll love this job. I hope it's of some help, cheers John J
John J
 

What EXACTLY does a CRA do?

Postby Dave Jensen » Thu Nov 04, 2004 12:54 am

Hi Jessie,

I appreciate John's comments, they are very good -- right on target. Here is a job description I clipped from my files that may help you as well. This is for the Boston area, but the CRA position should be the same anywhere:

Clinical Research Associate Job Description:

Key participant in the design, implementation and monitoring of clinical trials, preparation of integrated medical reports, INDs, Investigational Device Exemptions (IDE), periodic reports, New Drug Applications (NDAs) and Biological License Applications (BLAs), etc. Participates in design and writing of protocols, case report forms and informed consent forms for clinical trials. Productive in recruitment/selection of new investigators, contract research organizations and outside vendors. Responsible for planning and implementing all activities required to conduct and monitor complex clinical trials and ensures that Good Clinical Practices (GCP) are followed. Conducts site visits pre-study, at study initiation, at regular intervals during the study and at study closeout. Monitors investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary. Ensures that Case Report Forms (CRF) are reviewed in a timely fashion and submitted to the data management group. Involved in the compilation/writing of integrated medical reports and clinical sections of INDs, IDEs, New Drug Applications (NDAs) and Biological License Applications (BLAs)), etc. Assists in preparation of presentations and manuscripts of scientific meetings and technical journals. Attends scientific/professional meetings and training courses as appropriate.

Education/Experience:

Senior positions require BS in a scientific, health care field and 5-8 years' experience in the pharmaceutical or device industry including relevant clinical research experience. Intermediate positions require BS in scientific field and 2-4 years related experience. Knowledge of FDA regulatory requirements is preferred for both Senior and Intermediate levels.
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What EXACTLY does a CRA do?

Postby Eric » Wed Dec 29, 2004 5:38 pm

How does one become a CRA? Am I correct in assuming that the only real way to enter this field is to be an employee at a pharmaceutical company who already has some involvement in clinical research, and that there are no entry level openings for people with no real experience in clinical research?
Eric
 

What EXACTLY does a CRA do?

Postby Dave Jensen » Wed Dec 29, 2004 6:42 pm

Eric,

It is one of those kind of positions that never gets advertised. You'll never see "Entry Level CRA needed, no experience required."

However, it is the same way with Sales Rep jobs. You never see an ad seeking a person without any sales experience to be a sales rep for a pharma or biotech company. And yet, they are hired that way all the time.

They have the (often difficult) job of a tough networking process combined with convincing the hiring manager that they will succeed -- whether it is a sales job or a clinical job, hiring managers operate the same way. They know that they will have to work harder for a number of months to help get that new person up to speed. But, if it is a person they LIKE and someone who has ENTHUSIASM and a real interest in their company, they often go with it.

And as another thread says, don't forget that often the entry level jobs for CRAs are filled by temp staffing firms such as Kelly Clinical (a unit of Kelly Scientific Resources), Yoh Scientific, Ramstadt (spelling?), and others.

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