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Clinical Research

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Clinical Research

Postby Toby » Mon Jan 24, 2005 11:27 pm

Hi,

I will be graduating this year with a B.S. degree in biology. I know I don't want to pursue a Ph.D. degree and am looking into alternatives. I was thinking about going into clinical research and was wondering what experience does one need to get into this field? Is a B.S. degree enough? Is a nursing or R.N. degree preferable or necessary to get a higher position? Also, could anyone explain why clincial research associates have higher salaries than research techs/assistants? I would think someone in the basic sciences is more skilled technicially than one in clinical research. Is it b/c there are more staff in upstream research than the downstream? Thanks for the help.
Toby
 

Clinical Research

Postby Lora » Tue Jan 25, 2005 3:01 pm

It depends on what you want to do in clinical research. With a BS, you will be limited to technician or junior associate status. This isn't necessarily a bad thing, depending on what you want to do with your career, how much time (social and personal life) you're willing to sacrifice, and how much responsibility you want to take on. Clinical associates are on call in the event that something goes horribly wrong with the testing (e.g., a patient enrolled in one of the studies has an adverse reaction, the FDA drops by for a surprise audit, or, heaven forfend, the CEO is served with a lawsuit and your notebooks are seized).

An RN will get you higher up in the chain of command, and RNs in clinical research are both in immense demand and well-compensated. Many schools have RN programs that only tack another year or year and a half on to your BS, and there is usually plenty of scholarship money for anyone pursuing an RN, so if you want to get into clinical work, definitely consider a nursing degree as well.

One reason clinical research has such a huge pay differential is that the level of responsibility is on a completely different scale than any other research. Clinical research must be carried out in a regulated environment, and the research has to conform to certain quality standards; most academic and many industrial researchers find these regulatory requirements overwhelming if they've never encountered such a degree of oversight. The FDA holds individual researchers--yes, even the low-level techs and junior researchers--personally accountable for ethical breaches and quality control failures, as well as holding the company responsible. The FDA even keeps a blacklist of researchers and technicians who have been convicted of ethical wrongdoing. Companies that produce pharmaceuticals and medical devices provide regular training on the regulations that clinical researchers must work under, and there will be quality assurance people who will help you understand the regulations, but a very thorough understanding of 21CFR takes years to build. I cannot emphasize enough: most academics and non-regulated industrial scientists find the documentation, planning, and liability of GLP/cGMP suffocating. You must have the patience to read what seems like terminally boring legalese before you're allowed even to put on your lab coat.

To get an idea of the way clinical research works, visit fda.gov and look at 21CFR part 312--that's the part that applies to clinical drug research. Part 601 and 610 apply to biologics, parts 812-888 apply to medical devices.

Personally, I rather like doing medical device research: you will never, ever wonder, "What am I doing here?" because the answer is always, "saving lives."
Lora
 

Clinical Research

Postby Erin » Wed Jan 26, 2005 10:26 am

Lora,

Do you know of specific schools that offer the post-BSc option that you mentioned? I can't find any (although I've only looked into Canadian schools so far).

Thanks.

Erin
Erin
 

Clinical Research

Postby Lora » Wed Jan 26, 2005 1:35 pm

Erin:

Cleveland State University has an 18-month RN program that has scholarship money available from (I think) the Cleveland Clinic.

The Gordon and Betty Moore Foundation funds an accelerated nursing program at San Jose State University in Santa Clara, CA.

West Virginia University in Morgantown, University of Massachusetts-Amherst, University of North Carolina-Chapel Hill have 14 to 18-month post-BSc nursing programs, although I don't think they provide funding. It seems like most large nursing programs have some sort of accelerated program for people who already have a science-related BS.

Hope that helps!
Lora
 

Clinical Research

Postby AL » Wed Jan 26, 2005 7:10 pm

Thank you for these incredibly informative posts Lora!
AL
 

Clinical Research - Thanks Lora

Postby Toby » Wed Feb 02, 2005 8:07 pm

Thanks for the info Lora. I have another question and I'm not sure if you can answer it or not. If I do decide to get an RN, do I need some prior training (like working at a hospital) before going into clinical research? Also, would it be better that I start off as a technician or clinical associate and then get the RN part-time? Will it therefore be easier to get into the field if you have prior experience?
Toby
 

Clinical Research - Thanks Lora

Postby Lora » Thu Feb 03, 2005 8:37 am

Toby:

Good questions! Every RN program I've ever heard of, including the community college sort, have a clinical hands-on component to them. While some experience in specialized patient care (ICU, pediatrics, whatever) might be nice, it's not required as far as I know. If you do go that route, you would probably want to select a specialty based on pharmaceutical trends: oncology, cardiology, neuro, etc.

Re: working part time for a company before getting your RN. There's a trade-off here. While you are correct in noting the importance of getting one's foot in the door, there are some drawbacks. One, if you are a really really good technician, your boss might not want to let you leave his/her group, and could make a transfer up into a new job within the company difficult. Two, you may find that company loyalty means nothing more than, the company feels they can pay you less than they would need to spend attracting a new recruit--you may find that your boss tells you, "Congratulations on your RN and your new position, we're giving you a 15% raise!" and then you find out that new hires are getting a LOT more than you. Your first salary at any job grade tends to predetermine future salaries, so this is important. You have to balance those drawbacks with how much companies value industrial training, which in this case amounts to regulatory (in this case FDA-governed) training. It's kind of a toss-up, really, and depends largely on the particular company you want to get into; some companies value the fact that you're able to do science in this regulated environment, some value more that you have a thorough knowledge of the regs (as in QA or Legal departments).
Lora
 

Clinical Research - Thanks Lora

Postby Toby » Mon Feb 14, 2005 11:32 pm

Hi Lora,

Thanks again for the suggestions. Currently, I am working as a tech in a pathology lab in basic research at one of the top cancer research institutes. My career strategy is that I am hoping to find an entry level job as a clinical research assistant to obtain some experience and then work on a R.N. degree (probably in oncology based on work history) part-time (hopefully the tuition will be reimbursed). Then after my degree and some experience I would look for a job in the pharmaceutical industry.

I was also wondering would my several years of basic research experience as a tech help or benefit me in anyway as I head into the field of clinical research? Or is it an entirely different frontier?
Toby
 

Clinical Research - Thanks Lora

Postby Lora » Tue Feb 15, 2005 8:21 am

Oh, absolutely it will help to show you've done cancer research! Look at it this way:
-Most RNs have oodles of clinical experience but barely remember the science of why they do what they do. You not only remember it, but you're practiced in it.
-Most techs have zero clinical experience, and can't deal well with people. You will have the RN and clinical experience, to show you're good at that too.

This makes you a highly employable candidate. I would wish you good luck, but I don't think you'll need it!
Lora
 


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