CRA equals "billable hours" to CRO sweat shops who all use "Efficency Rating Scales"

Get new comments by email
You can cancel email alerts at anytime.
Comments (101 to 129 of 129)
Page:  « Previous   1  2  3   

CRABLUES in San Diego, California

92 months ago

To UNK in San Mateo: One of the best managers I have ever had told me that everyone feels that they "own" pieces of any given study, protocol, CRF, etc. To them it is personal,and belongs to them, when it reality, it is a job. The job needs to be put into perspective. It is a paper reflection of the job and every job needs to be well done. It is the bullying and the back biting and the metaphorical cutting off at the knees of others in the profession that leads to poor data, vague end-points, an abundance of queries and ultimately the denial of approval. It is at the crux of 483.If everyone focused on the science and the benefit to the patient, the protocol would be followed, amendments would not be necessary,and if everyone could remember that study patients are people with families who love them, the ethical standards would become second nature. If money was not the driver for performance,every company would have only the best, the brightest and most ethical people working there, but since that is not the world we live in, we are required to do the best with what we are given. It is unfortunate that you have a MSN degree and have no ability to respect another person's view. All that education and you think you can get inside my head and tell what I am "really" saying. Well, here is what I am really saying, The days of good science, clean data, and focus on the rights of the patient have taken a back seat to financial gain at the expense of the patients. It is the CRA in our field who sees this demise.

- Was this comment helpful? Yes (5) / No Reply - Report abuse

Eager n Desperate in Toronto, Ontario

92 months ago

Hi Everyone.
I'll be finishing my post-graduate training in Clinical Research at Humber College in two months time. Personally I think the program was EXCELLENT, taught me a great deal about clinical research processes, important regulations, and major roles and responsibilities of Sponsors, CRO, IRB.... I am ready to start to work as a CRA but like everybody else has said, it's really hard to get into the industry, especially given the economic situation these days. I would like to look for a position in Canada, if possible, so if you guys know or can recommend any pharmacompanies, or CRO's please let me know. Any advices or recommendations as to how to break into the industry would be extremely helpful too. I've read some of the posts and i think I am pretty confident that I won't be one of those "inexperienced" CRAs that some of you had to clean up after....^^ or is this me naive thinking?^^
Any help/comment/feedback would be greatly appreciated.
Thanks

- Was this comment helpful? Yes / No Reply - Report abuse

CRA in Greensboro

87 months ago

I saw the post from Jon@CRAlife.com and I think that this site is a scam. I sent an e-mail to them and was invited to join which I did in good faith. Then I get an e-mail saying that I have been banned with no explanation and no response to my requests for an explanation. We certainly do not need this type of capricious behavior when trying to have a serious discussion about the life of a CRA. I have only been doing this for 2 years but find it the most fascinating job I have had to date. I am an RN with 20+ years of experience both in management and out, hospital to insurers. This is the best job!

- Was this comment helpful? Yes (3) / No Reply - Report abuse

lanfear in Sicklerville, New Jersey

87 months ago

CRA in Greensboro said: I saw the post from Jon@CRAlife.com and I think that this site is a scam. I sent an e-mail to them and was invited to join which I did in good faith. Then I get an e-mail saying that I have been banned with no explanation and no response to my requests for an explanation. We certainly do not need this type of capricious behavior when trying to have a serious discussion about the life of a CRA. I have only been doing this for 2 years but find it the most fascinating job I have had to date. I am an RN with 20+ years of experience both in management and out, hospital to insurers. This is the best job!

I don't know why you got bounced, but I am on it. Site isn't a scam, but there has not been too much activity lately because I think everyone is so darn busy. For all those people considering becoming CRAs. RUN! If you value not having a life, living out of hotel rooms, and never having time to properly eat or sleep, this is the job for you. Otherwise get out.

- Was this comment helpful? Yes (1) / No Reply - Report abuse

Jannie in New York, New York

86 months ago

Do any CRA's that are contractors through an agency get paid time and a half over 40 hrs? I have heard some do, some do not. There are also questions as to whether you are truly an independent contractor according to IRS rules

- Was this comment helpful? Yes / No Reply - Report abuse

up2me in Providence, Rhode Island

86 months ago

Jay Chantlos in Tampa, Florida said: Disillusioned,

I sincerely apologize for the way you were treated and the lack of response you received from your recruiter. Please contact me and let me know the recruiter you have been working with so we can get to the bottom of this. I want to make sure this doesn’t happen in the future and you have a clear understanding of the opportunities that we have. If you can email me at jchantlos@kforce.com I will respond to you by the end of the day.

Regards,
Jay Chantlos
Market Manager
Kforce Clinical Research

Hello Jay, you seem sincere in your gesture of making things right. This is my first time viewing this site and am really shocked at what I'm reading. I have been a research nurse for 9 years and the site coordinator for 3 of the 9. I've been feeling a need for a change and thinking of the CRA position. I work in a small hospital based clinic doing NIH and Industry trials. I have actually had Kforce call me asking if I could refer anyone for a CRA position. This is really not what I expected. Sounds like a "pressure cooker" environment and not worth the stress???
Wishing everyone the best outcome!
P

- Was this comment helpful? Yes (1) / No Reply - Report abuse

JKCRA in Owensboro, Kentucky

85 months ago

Hi all,

Firstly, I started with Quintiles and I think their training programs are excellent. I had SC experience before I went into entry level CRA, 5 years ago, and I have never found them to be lacking in training, dedication to quality, or swift action against unethical sites.

That being said, I just resigned from them! No other job lined up yet, either. My travel was far from regional and I simply can't do it anymore. My performance evals were great and I kept being told I was first in line for a Lead CRA position or team lead, but it never came about. I was actually told once that I was not going to be promoted because I was too valuable on the road. I love clinical research and would love to stay in the industry, but I can't keep up the site load, study demands, AND the crazy travel. Just can't. Physically, I'm drained and I had to get off the road a while to save my sanity. Just hoping now that there is a company out there who wants an experienced, dedicated, hard-working CRA, but who DOES NOT wish to live in an airport anymore.

- Was this comment helpful? Yes (2) / No (1) Reply - Report abuse

SEEKSTRUTH in Dallas, Texas

80 months ago

Hello all,

I've been following this thread for a while. I will say 2 years into the CRA position, I am exhausted! It is true what they say about being overworked and constantly harrassed about data for deadlines. There is A LOT of travel and I agree, it really takes away from your quality of life. I am a CRO trained CRA and I know I feel I could use a lot more training.

As I monitor, I ask questions and challenge some of the information I review, only to be punished afterwards because I could not pull full cycles. In short, production rules the world! I'm somewhat indifferent about having a medical background prior to entering this field--I really feel people came be taught anything--but I TRULY believe project managers should CRA experience. In my experience, the ones that don't just don't get it..

JK--I totally agree, I am to the point where I just cannot do this anymore. I love the role of a CRA, however the job is killing me.

- Was this comment helpful? Yes (2) / No Reply - Report abuse

CRA in Fairfield, Connecticut

80 months ago

Seekstruth,
Have you thought about transition to an in-house CRA/site manager role at a pharma or biotech?

- Was this comment helpful? Yes (1) / No Reply - Report abuse

SEEKSTRUTH in Dallas, Texas

80 months ago

Im reluctant to transition in house! I'm not sure if I want to deal with the office politics.

- Was this comment helpful? Yes (1) / No Reply - Report abuse

Nina in Singapore, Singapore

79 months ago

I was volunteering in a research unit in LA county hospitals for 6 months before working as SC for 3 years in the US, then i was hired in Q asia as CRA and now after working for 3 years 5 months, i am a Sr CRA 1. After working for 1.5 years, I was offered to work at home (home based CRA)since i was a mother with 3 children. When my office grow and more news CRAs were recruited, my traveling time is highly reduced. I enjoy being homebased CRA and i enjoy working in Q. If the monitoring times is not enough, i will inform my LM that i need more time. My LM was great and he ask me to take more time as i need as non billable hours to ensure the monitoring's quality was reached. There fore i never see the hours limit that was set in the guide line as a wall. I know it probably difficult for the contract CRA, since their hours are always billable.

- Was this comment helpful? Yes (1) / No (2) Reply - Report abuse

wide-eyed in Marietta, Georgia

78 months ago

I just discovered this site. I see that there are no posts in 2 months. How is everyone doing now? Are you finding part-time CRA contract positions out there these days?

- Was this comment helpful? Yes (1) / No Reply - Report abuse

elizabethlizardo in New York

75 months ago

Hello All!
i am in an active search for a Senior Clinical Research Associate that is located or is willing to Relocate to Birmingham, AL.
This is a 6 months contract position with a Reputable Pharmaceutical Company, i am searching for a Sr. CRA with both Cardiovascular and Diabetes Experience, if you match this description, please contact me elizabeth.lizardo@acsicorp.com, include and Up-to-date resume.

Many Thanks
Elizabeth Lizardo

- Was this comment helpful? Yes (1) / No Reply - Report abuse

Sunshine in Fort Worth, Texas

74 months ago

I am interested in an internship or an entry level position. I have been out of work for 12 years due to raising 6 children. I am 32 and I am an honor student with Argosy University. I am a junior working on my BA in Psychology, concentration- forensic psychology. I am interested in any form clinical and neuro. Just need to get my foot in the door. Anyone know have ensight that are willing to share with me as to how I should go about gaining some experience? Thanks.

- Was this comment helpful? Yes (1) / No Reply - Report abuse

Tober J. in Charlotte, North Carolina

73 months ago

SEEKSTRUTH in Dallas, Texas said: Hello all,

I've been following this thread for a while. I will say 2 years into the CRA position, I am exhausted! It is true what they say about being overworked and constantly harrassed about data for deadlines. There is A LOT of travel and I agree, it really takes away from your quality of life. I am a CRO trained CRA and I know I feel I could use a lot more training.

As someone who worked as a CRA for several years, traveling at > 75%, it is true that it can be rough. It takes a lot of effort to balance life and work with such a position. As to deadlines, it is hard to keep up sometimes, and it becomes even harder the further up the ladder you go.

As to your comment regarding training: As a CRA Manager for a CRO, I would be interested to know what type of additional training you feel that you could benefit from. I try to take a position of nurturing my CRAs and giving them the tools they need to succeed, so feedback like this is beneficial. I know the responses to this question I get from my own CRAs - I would love to hear from you (or other CRAs) as well.

SEEKSTRUTH in Dallas, Texas said: In short, production rules the world!

Agreed. But that is corporate industry for you.

SEEKSTRUTH in Dallas, Texas said: I TRULY believe project managers should CRA experience.

Agreed. I think monitors should have coordinator experience too. I find that monitors who have worked for a site also have a better understanding of that role, and can function as better CRAs as a result.

SEEKSTRUTH in Dallas, Texas said: I am to the point where I just cannot do this anymore. I love the role of a CRA, however the job is killing me.

It took me about 4.5 years to work my way up from CRA I to a CRA manager position. I still have a TON of work to do on a daily basis, but my travel is now well under 20%, which is huge. Hang in there.

- Was this comment helpful? Yes (3) / No Reply - Report abuse

RN in San Francisco, California

72 months ago

Living in "Biotech Bay", I've taken several courses at local Universities (Cal Berkeley, UC Santa Cruz &
SF State) As a "Life-Long Learner", the experience was great, but what a waste of $$$.
I'm an RN making 130K/year. Do you think for a NY sec that I'd give that up for a CRA
gig making 60K ??????

- Was this comment helpful? Yes (2) / No Reply - Report abuse

Mather in Pittsburgh, Pennsylvania

54 months ago

JKCRA in Owensboro, Kentucky said: Hi all,

Firstly, I started with Quintiles and I think their training programs are excellent. I had SC experience before I went into entry level CRA, 5 years ago, and I have never found them to be lacking in training, dedication to quality, or swift action against unethical sites.

That being said, I just resigned from them! No other job lined up yet, either. My travel was far from regional and I simply can't do it anymore. My performance evals were great and I kept being told I was first in line for a Lead CRA position or team lead, but it never came about. I was actually told once that I was not going to be promoted because I was too valuable on the road. I love clinical research and would love to stay in the industry, but I can't keep up the site load, study demands, AND the crazy travel. Just can't. Physically, I'm drained and I had to get off the road a while to save my sanity. Just hoping now that there is a company out there who wants an experienced, dedicated, hard-working CRA, but who DOES NOT wish to live in an airport anymore.

I think that you did what was best for you and a admire your courage. I find that they are people, especially in the CRO business that will work you until you simply cannot take it anymore. I make it a point to let me boss know that I am satisfied with my workload when it's easy and I always speak up and ask for help when I cannot. If I speak up and request help, they know I am not one of those people who can be taken advantage of in the workplace.

When the travel isn't regionalized, it's nearly impossible to do more than 2 IMVs a week. After all, with the airlines today, it practically takes a whole day to travel just about anywhere that's >500 miles away and it's it makes doing that many days on site extremely difficult and requires one to be over extended.

Living your life constantly overextended is not a life anyone ever dreams about.

- Was this comment helpful? Yes (2) / No Reply - Report abuse

Jill CRA in Chapel Hill, North Carolina

49 months ago

And here I thought I was the only one this happened to! :-(

Burned Out in Spokane, Washington said: When I cleanup sites behind other monitors I have frequently been berated for finding and reporting significant issues the previous monitored missed. Burne

- Was this comment helpful? Yes (2) / No Reply - Report abuse

anca in Vaudreuil, Quebec

44 months ago

Stefan Viziru in Edmonton, Alberta said: "It was very very difficult to get in to the industry, but the good news is that once you get in, you are really set".

Yeah, SwissHam is perfectly right, the first Clinical Research job is the hardest to get. And I hear that song "you are too overqualified" too often. They afraid people will leave them later but don't seem to understand in our times anybody leaves when he/she gets a better paid job. So the point is to pay accordingly, othwerwise they lose people.

I am more and more depressed, today I applied for the 201st position (!!). I have less and less confidence, without networking probably it is very very difficult.

You are right, indeed is tough - but I have been there and I can tell you that after 800 submissions (resume and cover letters - all tailored for the targeted role) I did not lost hope. Of course I was sometimes discouraged since I had no network whatsoever - but you can buid it. There certainly are in your city conferences, workshops for the public...go to them and try to talk to the key persons...try to get contacts, explain that you have such credentials and you are asking for their help - they generally are willing to help.

Go out there and do your best, stay open, honest, and the lightening will strike - and this IS NOT JUST A MANNER OF SPEAKING. It's working, I can promise you.

I am just not willing to monopolize your time, so I will stop here.

Best regards,

A

- Was this comment helpful? Yes / No Reply - Report abuse

christymandacina@*****.*** in Smithville, Missouri

42 months ago

Quality Seeker in Massachusetts said: Hello, I wanted to thank you for all your posts. Ive never been on this site before and dont usually post messages, but this is the first time Ive heard anyone express some of my own frustrations.. so here I am
I currently work as a Director of a Clinical Operations for a small biotech , but prior to that spent several years as a CRA and then Clinical Project Manager
In 2005 I was working as a global CPM for one of the large CROs (No "P" in the name!), and had done extremely well in this role..that is until they started seriously underbidding on proposals. I ended up being allocated to multiple projects at 20-25% each, where in reality it should have been three times as much. Of course the client complianed about me not getting things done.
I wasnt fired, but my self confidence took a serious beating through negative performance evaulations, and general lack of support. I simply wasnt following the party line and eventually it became intolerable for me to be there..so I left.
I still butt heads with people who just dont get how much work it is to run a trial, or that regulations arent supposed to be adhered to selectively!

Thanks for sharing, I am currently a CRA who has been asked about management and I keep turning them down. My husbands says 'but its less travel' and I say the payoff isn[t near enough! so I believe after reading your post, I'll keep saying no. Oh, and I was offered to resign because of a complaint against me as well! Anyone see a pattern here?????
cbm

- Was this comment helpful? Yes / No Reply - Report abuse

christymandacina@*****.*** in Smithville, Missouri

42 months ago

Opps! I meant 'husband'!!!!!!!!!1 NOT husbands! lol

- Was this comment helpful? Yes / No Reply - Report abuse

seasoned monitor in Gilbert, Arizona

41 months ago

Jill CRA in Chapel Hill, North Carolina said: And here I thought I was the only one this happened to! :-(

No, I think it's happened to many, many of us with more than 10-15 years experience. I've had this discussion with many colleagues over the past 5 years. The result of these kinds of practices is that work is done sloppily and ends up being re-done by more experienced personnel at a far greater cost. That's what I've spent much of the last 5-10 years of my career doing: cleaning up after over-worked, burned out monitors.

- Was this comment helpful? Yes (2) / No Reply - Report abuse

seasoned monitor in Gilbert, Arizona

41 months ago

You just gave me an idea for one. I've been thinking about doing a blog for a while now, and perhaps this is exactly what I'm looking for. I, too, have many, many years as both a contract and permanent CRA and have seen much evolution in the industry, a lot of it, not good. I was laid off nearly 2 years ago because I wouldn't buy into the CRO model of 10+ reportable visits...i.e., it didn't matter if the visit took 3 days to complete, I only had one report to write and therefore had to complete another 9 visits to meet the metrics of the company. As a new mom, I simply didn't want to be away from home that much. Nor is it necessary, if a study is adequately staffed and managed.
Site managers are a myth in today's world. You can't possibly be a site manager and be on the road 3-4 days a week. It's not fair to the site you're at,your other sites, not fair to the study when you have to constantly take move your focus during a monitoring visit. Not to mention, when you ARE spending 3-4 days on the road, at least 2 of those days are going to be 18+ hour days.

- Was this comment helpful? Yes / No Reply - Report abuse

seasoned monitor in Gilbert, Arizona

41 months ago

Quality Seeker in Massachusetts said: sorry, hit reply too soon.

As someone who now hires..and just in fact fired 2 CROs for incompetence, Im struggling to find individuals who actually know what theyre doing...even the so called experienced ones. dont ever compromise what youre doing..there is someone out there who will appreciate your value and skills.

I would love to be able to contact you privately, though I'm not sure how through this forum. I and a number of colleagues and friends are looking for contract work, most of us with well over 10 years, most closer to 20, experience.

- Was this comment helpful? Yes / No Reply - Report abuse

Anon. in Mundelein, Illinois

19 months ago

Burned Out in Spokane, Washington said: Hello Linda and Stefan

I really appreciate your responses. I wish there was a good CRA blog where experienced CRAs can expresss their views. The bottom line is the job of a CRA has become one of production instead of quality because the job description has been defined by CROs.

Several years ago I wrote my Master's thesis on the conflict of interest dilemma facing CRAs. Do you report bad study conduct or do you keep your job? Also, there is no where for CRAs to report fraud or study misconduct. CRAs somehow need to take control of the CRA role to accomodate the "intent" of the federal regulations to ensure the welfare of human subjects and to ensure that fraud is not being committed. Experienced CRAs need to develop both a written code of CRA ethics and a CRA Bill of Rights. Many professions such as nursing have these documents. The role of the CRA needs to be redefined by the people who do the work not by efficiency ratings. Do either of you know how this might be accomplished?

For reading about the quality of work from CROs and the problem of production over quality try to get the Applied Clinical Trials article "CRO Model Takes a Hit" from 19 October 2007. This will refer you to a NEJM article.

There is a way but yes, do you want to keep your job. If there is documentation which clearly indicates violation intent and you believe they are severe enough, you can make copies and send all of this information to the FDA, Division of Scientific Investigations. You can remain anon. You've gone as far as you can. The FDA will decide if this is worth an investigation, most likely "for cause."

Have you considered contracting? You may not have a job 100%. I look at this time off as "unpaid vacation." Plus it's $50-85/hr - this makes up for no benefits.

- Was this comment helpful? Yes / No Reply - Report abuse

Ethical in Herndon, Virginia

15 months ago

I know what you mean.

As an PPD employee I raised several ethical concerns about my boss and they ened up firing me. I went to teh Ethics Comitte and to Senior management and they dismissed my concerns as non-existent, though they never investigated them.

PPD is certainly not an ethical company , despite their claims

- Was this comment helpful? Yes / No (1) Reply - Report abuse

seasoned monitor in Phoenix, Arizona

15 months ago

seasoned monitor in Gilbert, Arizona said: I would love to be able to contact you privately, though I'm not sure how through this forum. I and a number of colleagues and friends are looking for contract work, most of us with well over 10 years, most closer to 20, experience.

I apologize, I never saw this reply. I've since stopped monitoring anything but local sites altogether, opting instead to do my M.Sc. in Clinical Research Management in the hope of getting into PM or even better, medical writing or teaching new monitors. I would definitely be interested in speaking with you, but I've no idea how to do private things in this forum.

- Was this comment helpful? Yes / No Reply - Report abuse

Teri Andresen in Cathedral City, California

5 months ago

Jay Chantlos in Tampa, Florida said: To All,

As a recruiter for Kforce Clinical Research Staffing everything I have read on this forum is not NEW news and is something I hear everyday from candidates. The struggles that folks face in the CRO world is very unfortunate and it is a shame that you are not valued more. I was curious to see what your thoughts are of my company and if you view us as a staffing firm in the same light as a CRO. Please be honest and if you are unfamiliar with Kforce I would be pleased to let you know more about us and the way we conduct business and value our employees.

Regards

Hi,

I would like to know more about Kforce. I have heard great things about your company and am looking at entering the CRA world. I have just completed by BS in psychology and have 14 years of clinical research coordinating and regulatory experience in the areas of HIV, Oncology, Diabetes and cardiovascular diseases. Please contact me at tediandresen1@gmail.com

- Was this comment helpful? Yes / No (1) Reply - Report abuse

DoomedbyGoogle in Irvine, California

2 months ago

The sad truth is companies dont want to know the trurh. They just want their enrollment numbers and get the drug on the market. After 10 yrs as a CRA I saw too much. Buyer beware - drugs are NOT thoroughly tested.

- Was this comment helpful? Yes / No Reply - Report abuse

Page:  « Previous   1  2  3   

» Sign in or create an account to comment on this topic.