job opportunities as a CRA

Dear,
someone will tell me job future of this position?

thanks

Hello Sunil,

The future of the CRA/ site monitor occupation may be different in Canada than in the USA. Here in the USA the Food and Drug Administration (FDA) have not been impressed with the quality of monitoring at investigational research sites since 1999. They have recently indicated that the quality of monitoring of clinical research sites is steadily declining. The FDA believes this may be happening because the rapid turn over and burn out rate of CRAs is less than 2 years. This means the industry is constantly replacing CRAs who have some experience with new and inexperienced CRAs. Hence, the CRA workforce is largly comprised of people who have a heartbeat instead of people who are skilled which keeps the quality of site monitoring low.

I am telling you this because if the FDA should ever really take control of how clinical research sites are monitored in the USA, then, there will be major changes in the occupation of a CRA here in the states. But in Canada, doesn't the Ministry of Health oversee the quality of monitoring?

by rapid turn over and burn out rate what exactly do you mean? people getting tired of traveling so much?

Chris R in Phoenix, Arizona said: by rapid turn over and burn out rate what exactly do you mean? people getting tired of traveling so much?

repetitive work..think as a paper work sweatshop labor in a cubicle only that this cubicle is different everyday and at a different site and yes, the traveling is ok at first, but once you get a family, it becomes difficult.

most cras hired these days are all previous bio majors who decided to not persue medschool or postpone it...after 2 year or so, most of these cra feel they have enough exposer to help their med school app...thus they leave for a better future or to other companies with higher wages

thus the high turnover rate...theres a reason why CROs are always looking for new CRAs

Chris R in Phoenix, Arizona said: by rapid turn over and burn out rate what exactly do you mean? people getting tired of traveling so much?

Hello Chris R,
There are a host of reasons causing the rapid burn out of CRAs. Amongst them are:
-Travel - In addition to the actual nightmare of traveling, there is the scheduling of the travel, the writing of expense reports, and for some of us constantly being in a different time zone. The travel alone is another 40 hour work week.
-Extreme Multitasking- The new description of CRAs as "Total Site Managers" has given employers the opportunity to overloaded CRAs with tasks that employers (especially CROs) expect CRAs to perform all at once. I will try to find the reference to a recent article about all of the expectations of CRAs. Although this article appeared to be written by someone who was not actually a CRA, the big picture of the article is true. CRAs have too many hats to wear and you burn out from trying to do everything.
-Ethical Dilemmas- The ethical dilemmas are profound. Just one
of these dilemmas is that you have to decide between keeping your employer happy by meeting their impossible production expectations or do you keep yourself happy with the satisfaction that you are doing quality work that lives up to the "intent" of the federal regulations instead of the "word" of the federal regulations. Believe me choosing to perform quality work will not get you promoted at a CRO. But if you prize promotions over the satisfaction of doing a job well, than perhaps the position of CRA is for you. There are many other ethical issues that I do not have the space to discuss.
In short, CRAs have to make many sacrifices and "give up their being" to performing CRA work. Also, go to the Health Blog at Wall Street Journal and read the comments about the article on the Merck Scientist found dead in the lab.

Are these issues becoming more prevalent now or have they always been part of a CRA's work? Is the work done at the sites just incredibly repetitive and mundane? What sort of "impossible production expectations" do you have to deal with?

Appreciate the input

Dear Chris,

The issues are becoming more prevalent because the CROs have been allowed to "define" the roles of the CRA. Like nurses, CRAs need to somehow find the power to redefine the job. CROs are increasing in numbers so the problems will continue to get worse. As more and more relatively untrained people (some newly trained CRAs)become project mangers who focus on productivity and efficiency ratings instead of the "intent" of the law the problems will increase. Drug companies want to be the first to get their product to market. CROs sell their services to drug companies by proposing they can be the fastest and least costly service. Ultimately, it is the CRA that is paying for the price for trying to comply with the CRO marketing of fast and cheap service. At this time there is no associations, or federal agencies that will stop it.
CRAs have not grouped together to make a change because people think of the position as a "stepping-stone" to bigger titled positions within large pharmas instead of a valid occupation.

By the way, a well kept secret is that study project managers at CROs are paid large incentives, in addition to their paychecks, for meeting very tight timelines and for making sure the projects are completed within the study budget. Due to these very large monetary incentives, project managers are very keen on tracking the efficiency ratings of CRAs. They will push us to beyond full-speed to get their incentives.

Ultimately, the rush to complete clinical research trials means that more and more bad drugs are being approved by the FDA and more and more patients are being hurt or die. It used to be very rare that an FDA drug marketing approval would be revoked. However, it is now a very common place occurrence. I am not against making money, however, it should not replace quality.

I admire nurses for being able to elevate their jobs to a more respected occupation. However, it took them much work and time to make changes.

Very interesting... I really had no idea that the CRA position is a stepping stone to being a project manager, whatever else... How long does it typically take to advance from a CRA position?

Hello,
I have completed my M.Sc in biotechnology and now am towards my completion of a postgraduate diploma in clinical research. I wish to join as a CRA and can anybody help me out for finding a relevant job.Please instruct me and inform me wherever an opening is there.I have an experience of 2 months but not in clinical research field.Jobs anywhere in pune,mumbai or bangalore will be great.thank u..

Hi Just a thought...
I am a 13 year very seasoned traveled CRA. I am 46 and just recently ceased the travel. I find issue with the 2 year burn out that is repeatedly menetioned. This seems to reflect the gen x- y whatever they call themselves group. My peers are all in their 40s to 60s and doing fine. Maybe besides "people with just heartbeats" , the lazy and weak should consider a starbucks 30 hour week to accomadate the huge burden. This is not an easy industry and many of us do work hard and are very compliant with ICH/GCP guidelines for well over a decade. This wimpy "burn out" nonsense...is just nonsense. I say get out or do the job you were hired to do! The pay is great the opportunities abound, the whinners maybe need to rethink their capabililites and motiviations.

It is not nonsense. It is the truth. People who are NOT used to the travel, can get burned out. It is not about complaining, just giving a correct depiction of how this industry CAN be and what you MAY be in for. Everyone has their own experiences and own dificulties, so just becuause you THINK it is so, does not mean it would be the same for everyone. I know tons of CRAs who have 30 some sites and spread across therapeutic areas in several states, so if they feel like whining, who the hell are you to say they shouldn't?

It is a stupid thing to say that people 'whine' about the truth of this industry. You do get burned out if you travel all the time. Plain and simple.

You mentioned...'The lazy and the weak'... very broad term here. So - you are saying what exactly - that those who meet 'your generation X definition' should all work at Starbucks - is this an official endorsement? Oh, I get it, that if a CRA complains in the slightest that the travel is getting to them, then they are 'weak' and should look for other jobs and question their capabilities in their profession? All because they complain about traveling.. hummm.. you have a very weak argument here sister.

I am surprised that 13 years in the industry did not breed you a better attitude.

This is to Heather in Spokane,

From your comments it is hard to believe that you have been a CRA for 13 years and have been successful. Part of the job of a good CRA is to get along with other people and your post did not demonstrate that you are able to do accomodate the views of other people. You actually sound more like a pharmaceutical sales rep or a coordinator that has recently become a CRA. If you had been reading the recent articles and (old articles) during your 13 year tenure you would know CRA burnout is worsening. The burnout rate is quite profound -travel is just part of the problem. However, as travel becomes more difficult it increases the burnout rate. I am in your age group so don't tell me that everyone in your age group (peers) are doing fine. I remember being able to go to a site and adequately monitor to ensure subject welfare, the integrity of the data, and the progress of the study. The job has gotten more than tough - it has become almost impossible to do everything required in a limited amount of time.
Be truthful with yourself and the folks looking to become CRAs. If you are one of the very fortunate few who do not travel and have just 5-6 sites and 1 protocol to manage than count yourself lucky but don't ridicule others for being truthful. The job of a CRA goes beyond tough because of people like you who have it easy that promote themselfs and then dictate what other CRAs should be doing. With so much experience you should be an advocate and a teacher not someone who sits upon a throne and judges others.
The work horses of the CRA industry should be able to complain, and complain very loudly. Perhaps changes will be made. I am surprised that as a wise and experienced CRA that you don't know to complain about the PROCESSES not the PEOPLE.
I am not impressed by you nor would I hire you as a CRA. Also you need to learn to spell, I can only imagine what your reports look like.
Master's degreed CRA

I am about to be hired as a CRA for a major CRO.

Quick Question: The traveling req'd is 80%. Can i expect to fly out on Monday and be back by Thrusday evening. (Please don't bash me. I'm a newb looking for info. I got really lucky and landed this job)

this is linked with all relevant appointment.
in any case you will have 4 days out!

Hi Burned out,

Thanks for sharing your industrial experiences I found it very helpful for those who intend to go into this field. I recently completed a PhD in pharmaceutical Sci and are thinking a career change, possibly CRA. However, after reading your comments about the current situation, I can't help worrying if becoming CRA is a right thing to do. What are other career options for CRA if they wish to make a career change? Is it possible for CRA to move to FDA for policy making or for CRA to participate in an instituational review board? Can you also share what is the difference working under CRO, contract or hired by big pharma?

Any advice is appreciated!

Hi Burned out,

Thanks for sharing your industrial experiences I found it very helpful for those who intend to go into this field. I recently completed a PhD in pharmaceutical Sci and are thinking a career change, possibly CRA. However, after reading your comments about the current situation, I can't help worrying if becoming CRA is a right thing to do. What are other career options for CRA if they wish to make a career change? Is it possible for CRA to move to FDA for policy making or for CRA to participate in an instituational review board? Can you also share what is the difference working under CRO, contract or hired by big pharma?

Any advice is appreciated!

Seeking advice! I am an RN and DVM in a country in Europe, currently I live in the US. Want to become a CRA. What are the possibilities and where you will advice to try since everybody wants experience ?! I heard they are companies that hire and educate you but you sign a 2 year contract. Any ideas ? Please, I need more concrete advices, Thank You !