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

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TCRA in Gillingham, United Kingdom

75 months ago

Hi, It is a good start to do a course on-line but it doesn't necessarily secure a job. I will suggest looking for jobs as Trainee CRA, the company will give you all the training or perhaps a CTA ( a step into the field). Personally, this online courses didn't work for me! But who knows you might be lucky.
People say it's hard to get into the field etc etc yes that maybe right but if you don't quit you will get something.

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Natasha in Toronto, Ontario

75 months ago

TCRA in Gillingham, United Kingdom said: Hi, It is a good start to do a course on-line but it doesn't necessarily secure a job. I will suggest looking for jobs as Trainee CRA, the company will give you all the training or perhaps a CTA ( a step into the field). Personally, this online courses didn't work for me! But who knows you might be lucky.
People say it's hard to get into the field etc etc yes that maybe right but if you don't quit you will get something.

Thanks a lot! Can you explain why this online courses didn't work for you? And what is your background? I am not really have necessary background (I have Bachelor's in engineering in Russia and diploma Registered practical nurse in Ontario (Canada). But I am interesting in this field a lot. Is it necessary to have greate knowledge in bio-... or samething like that? I thing it is possible to learn everything if there is wish. Thanks again.

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JCRA in Olympia, Washington

75 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.

With regards to your comment about a blog for CRA's, I wanted to offer something we are doing that is a bit different. I am the cofounder of a site called CRAlife.com. We are not recruiters, an agency, or CRO/sponsor. The whole purpose of the site is to create a private online community of CRA's. We launched two weeks ago and now have 200 members. It's free to CRA's and exclusive to CRA's. As membership grows, we will offer free services to CRA's, and pay for through advertising etc... It is invite only, which helps us to create the privacy we need. If any CRA is interested in checking us out, please send me an email at Jon@cralife.com.

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TCRA in Gillingham in Europe

75 months ago

Hi Natasha,
I have a biochemistry degree, worked in the lab for about 10 years, then worked as clinical trial coordinator for 1 year. So I am very new to clinical trial field, but working as trial coordinator certainly helped in getting this TCRA role. Personally, I checked out a few on-line courses and I thought a lot of them were extremely expensive...but if you do want to go that way make sure you take a FDA approved course.
So from my experience and others I think any avenue into clinical trials will help you to get to were you are heading. Reading a lot of articles and talking to people in the field is also very important.....most importantly networking
All the Best

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Natasha in Toronto, Ontario

75 months ago

TCRA in Gillingham in Europe said: Hi Natasha,
I have a biochemistry degree, worked in the lab for about 10 years, then worked as clinical trial coordinator for 1 year. So I am very new to clinical trial field, but working as trial coordinator certainly helped in getting this TCRA role. Personally, I checked out a few on-line courses and I thought a lot of them were extremely expensive...but if you do want to go that way make sure you take a FDA approved course.
So from my experience and others I think any avenue into clinical trials will help you to get to were you are heading. Reading a lot of articles and talking to people in the field is also very important.....most importantly networking
All the Best

Hi TCRA in Gillingham (I do not know your name). Thank you very much! I will try.

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TCRA in Gillingham in Europe

75 months ago

By the way look into using your diploma in nursing, this will certainly help in applying for jobs in a hospital as a trial coordinator. Most places want you to have patient contact experience and a science degree.
All the best
Eni

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Suzy wants to be a CRA in Sydney, Australia

75 months ago

WOw- what an incredibly informative site! Thanks everyone for speaking your mind. I came across the idea of being a CRA and loved the description, and the idea of getting away from the lab "wet" work and working with people. Becoming a CRA seemed like the perfect solution to entering into a great company as a valued employee and at the same time making good money... is this true for some companies I hope?? Are there any happy CRAs out there?
ALso, Does anyone have any information about companies hiring in Sydney for a Trainee position, i.e entry-level, no previous experience, no certification. I have my BSc. from the United States in Sports Biology and Chemistry as well my Masters in Biotechnology from The University of Wollongong here in Australia.
I also came across the KGR website to become certified as a CRA. Has anyone here actually paid for and finished this course who is now working for a good pharmac. company?
Is there anyone here who is a working, experienced CRA whom i can talk to either on the phone or via internet IM?

Thanks so much and i hope to hear from you!

Suzy

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Unk in Raleigh, North Carolina

75 months ago

Hi Suzy:

I absolutely love being a CRA and am so glad I made the move several years ago. I am an RN who fell into a Study Coordinator/Research Nurse position. After 6 years of doing that I was able to get an entry level position as a CRA at a top pharmaceutical company. They are hard to come by but if you have study coordinator experience you can do it. They tend to like to hire inexperienced people in-house as opposed to regional home-based positions. I now work for a global CRO for which I absolutely love. I personally will stay away from CRA positions in big pharma because pharma is just not as stable. They lay off all the time, however at a CRO it is us the CRAs who keep everything afloat as we are billable based on our time on site.

I would steer clear of any quick fix course that tells you at the end you'll be certified because you will not. Be careful to ask what they mean by "certified" because the nationally recognized certifications only come through well know groups like SOCRA or ACRP to name a few. You can't even apply for the certification test unless you have 2 years experience as a CRA full-time. You may have to start with an entry level position, in-house as a Clinical Trial Assistant first, but you will move up within a couple years. Good luck.

Senior CRA III

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Suzy wants to be a CRA in Sydney, Australia

75 months ago

Thank you Thank you Thank you, Senior CRA III, for such a quick response and such valuable information. Good to know these things!! Still, i want to hear from other CRAs (hopefully more happy CRAs) and gather as much iformation as possible. Does anyone else have even more informtaion or stories about how they came into the career as a CRA? As someone with NO experience in this field (only science degrees) i want to learn as much as i can before i jump into it.

Thanks everyone!

Suzy

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wants to gain work experience in Sydney, Australia

75 months ago

HI again - I wanted to know if anyone has any ideas, information, suggestions about volunteer work in the clinical trials field which might aid the progression towards getting a job as a CRA. I am an American living in Australia without a work visa, therefore a i have a lot of time on my hands for volunteering

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Debbie in Laguna Niguel, California

74 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 Jay,
and hello to everyone else. I am in the process of trying to get into the field of CR and I'm having a hard time and after hearing what the job is really like I'm feeling very discouraged. I am a licensed professional counselor (LPC) and I'm trying to transition from psychotherapy to CRA. What should I do to prepare myself and get into a good company. As a psychotherapist patient care is a priority with me - the only reason I'm making this shift is to make more money with better opportunities for advancement. I'm I a fool? Jay I personally delivered my resume to KFORCE in san diego. Any advice?

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Tampa, FL monitor in Palm Harbor, Florida

71 months ago

Moffitt is a starting place. They are still hiring --

Praveena in Riverview, Florida said: hi,

I am looking for entry level positions in clinical research field from tampa, Fl. I have done my masters in medical sciences. I have very little experience in the research field and i have received a training certificate for Clinical Research professionals from NIH.

Could anyone please guide me how to ptoceed further and mail me any openings for entry level.

thanks

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Tampa, FL monitor in Palm Harbor, Florida

71 months ago

Yes, you will have to choose between your own company ( therapy) or monitoring.

And... checking out the travel and expense monies that I have lost the last two years -- I am considering going back to the hospital. It was less stressful, and in the long run - paid more.

But - If you are looking to travel endlessly, work 7 days a week, give up meals at home, destroy your family life ( if you have one) become very anti-social -- Go for it! Being a clinical research associate would definately be a big change.

Did I mention depression? That follows the burn out phase...-- but then the angry phase hits again. A regional CRA occasionally has the feeling of their life being robbed by Nasty Ignorant CRO's. Welcome to the rollar coaster - strap up - it might be the ride of your life.

12 years of this life, and I have become appreciative of the small things in my life - that I really didn't pay attention to --

Best of luck to you & your family,
TB

Debbie in Laguna Niguel, California said: Hi Jay,
and hello to everyone else. I am in the process of trying to get into the field of CR and I'm having a hard time and after hearing what the job is really like I'm feeling very discouraged. I am a licensed professional counselor (LPC) and I'm trying to transition from psychotherapy to CRA. What should I do to prepare myself and get into a good company. As a psychotherapist patient care is a priority with me - the only reason I'm making this shift is to make more money with better opportunities for advancement. I'm I a fool? Jay I personally delivered my resume to KFORCE in san diego. Any advice?

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Tampa, FL monitor in Palm Harbor, Florida

71 months ago

wants to gain work experience in Sydney, Australia said: HI again - I wanted to know if anyone has any ideas, information, suggestions about volunteer work in the clinical trials field which might aid the progression towards getting a job as a CRA. I am an American living in Australia without a work visa, therefore a i have a lot of time on my hands for volunteering

Hi Work,

Volunterring in a foreign country -- is usually set up prior to going to that country - but Oh, well - it is what it is - right? Check with the American Embassy - Depending on how long you are going to be there, they can work on modifying your visa. You may have to obtain a work visa. Even while volunterring, a work visa is needed in most countries.

If you can modify your visa:
Kendle is the CRO to contact. They do train people-- (but you'd have to accept paymnet. Working for free is not an option) Of course, again, it would depend on your education level and their job descripts available for the area you are located.
Also could check the web sites under clinical trials for your area, these establishments may be able to lead you in a "volunteer" area working with Clinical trials - you never know till you look around..
Best of luck to you!

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Sandy in San Diego, California

70 months ago

HCSkorpio in Torrance, California said: Hi Debbie,

I think since you are a psychotherapist the easiest and quickest way for you to be a CRA is to be a clinical research / study coordinator. As a CRC / study coordinator you will be working with patients. Plus you will get into contact with CRA's who come in for the site intiation visits, monitoring visits etc. That will allow you some good experience to see what its like as a CRA, and to see if it's for you. Especially since you are going to do it for the money.

Being a CRA is not a bad choice, but if I were in your shoes I would think heavily about being a CRA and take into account your current personal circumstances. If you are dead set on it and are planning to advance your career you will most likely have to go through a CRO. Realistically the closest top tier CRO's are in San Diego. However if you become a CRA you can always move on up to a upper mid management position. I think you might be shooting for 90-100K but thats probably optimistic. You can choose to move back to orange county and work at the big sponsor firms as a project manager or the smallers CRO's in Irvine.

Good luck.

It is unfortunate that no one on this site emphasizes (or is aware of) the fact that CRAs SHOULD be trained in the medical field, so they will be able to read the medical records in addition to the source documents...? I keep having to clean up messes that the CRO CRAs have made. It is a shame. If you don't have a medical background, you have no business working as a CRA.

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Unk in San Mateo, California

70 months ago

Sandy:

Please do not put out there the stereotype that all "CRO CRAs" are not medically trained. I am an MSN prepared nurse and was a Study Coordinator 5 years prior to monitoring. I also worked for a major pharmaceutical company for several years and decided to move a large global CRO because it offered better work life balances, the corporate culture was absoutely a dream (compared to the unspoken rules of pharma's corp. culture), for the variety of studies I get to work on, and for the awesome upward mobility. These kind of "stereotypes" are so unnecessary! You comment "If you don't have a medical background, you have no business working as a CRA is so wrong. I know hundreds of CRAs that are and if there is something they do not know they ask. This industry is in dire need of more talented CRAs and to limit them to the requirement of having a medical background is so short sighted. I am an MSN prepared nurse and have see great leaders in our industry train these CRAs during protocol training... this is how it's done!

Love my CRO and will never work for pharma again.

Unk

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Josh Grob in Hamilton, New Jersey

70 months ago

Unk in San Mateo, California said: Sandy:

Please do not put out there the stereotype that all "CRO CRAs" are not medically trained. I am an MSN prepared nurse and was a Study Coordinator 5 years prior to monitoring. I also worked for a major pharmaceutical company for several years and decided to move a large global CRO because it offered better work life balances, the corporate culture was absoutely a dream (compared to the unspoken rules of pharma's corp. culture), for the variety of studies I get to work on, and for the awesome upward mobility. These kind of "stereotypes" are so unnecessary! You comment "If you don't have a medical background, you have no business working as a CRA is so wrong. I know hundreds of CRAs that are and if there is something they do not know they ask. This industry is in dire need of more talented CRAs and to limit them to the requirement of having a medical background is so short sighted. I am an MSN prepared nurse and have see great leaders in our industry train these CRAs during protocol training... this is how it's done!

Love my CRO and will never work for pharma again.

Unk

I just wanted to second that thought - there are some CRAs out there that do give CRAs in general a bad name. It is unfortunate that some companies do not do better to ensure their employees are trained better, but this is far from standard.

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Linda in San Antonio, Texas

70 months ago

Seven years ago I was "appointed" Study Coordinator even though I had no previous experience. Clinical trials was also new to the private practice I presently work for so there was no one to shadow. Needless to say, I had to "fly by the seat of my pants". I have come to realise I enjoy Clinical Research and I am ready to take the next step... being a CRA. Your comments have been helpful. Have any of you found the transition from Study Coordinator to CRA a plus in obtaining a position with a CRO and if so, how can this be done if most companies want at least 1 year CRA experience? The reason for my long intro was to describe my initiative. Thanks

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Unk in San Mateo, California

70 months ago

Linda:

Yes some CROs will take you on in an entry level position. I know that Quintiles has a special program to specifically hire Study Coordinator's (SCs) into new CRA positions. The program is called ACE, however I do not think they are hiring right now. Keep an eye on the Quintiles career job web site, just go to www.quintiles.com to look for ACE entry level CRA positions. Quintiles has an extensive training program to bring new talent to the industry. SCs have great experience, they just need to learn monitoring and integrate the knowledge base they currently have.

Be prepared to travel though. Quintiles requires CRAs to keep metrics of 8 days on-site per month for a month that has 4 Fridays & 10 days on-site for a month that has 5 Fridays. I do work at the "Q", previously as a CRA now as a Clinical Team Lead. I love it and will not work anywhere else.

Good luck.
Unk

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Travis in Morganton, North Carolina

70 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

I've also had a similar experience, Jay. I'm a monitor with a little over 2 years of field experience, and have posted for kforce jobs (Jobs.com) anywhere from New Jersey as both an in-house and field monitor (lived there before I moved to Chicago), PA as the same (willing to relocate) and Chicago, where I own a condominium. It's in my cover letter that I'd be willing to relocate, depending on the region, but you would have thought I would have received at least one reply to the postings. I'm currently living near the Charlotte/Asheville airports, but would prefer to go back to Chicago. Maybe I'm getting pidgeonholed into certain therapeutic areas? Would relo to become an in-house CRA for the oppprtinity and training into other therapeutic areas. Does everyone have to have oncology experience these days? All I hear is your resume looks stacked", but no results whatsoever after over three months of looking. Also have over 4 years of datamanaging experience.
Travis

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TB in Palm Harbor, Florida

70 months ago

Dear MSN prepared SC & CRA - Glad you enjoy your post at the big Q.
I do agree that people that don't have any medical knowlege generally don't have a clue about what they are reading in medical charts. Again, glad you are enjoying the CRO life.

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TB in Palm Harbor, Florida

70 months ago

Sandy in San Diego, California said: It is unfortunate that no one on this site emphasizes (or is aware of) the fact that CRAs SHOULD be trained in the medical field, so they will be able to read the medical records in addition to the source documents...? I keep having to clean up messes that the CRO CRAs have made. It is a shame. If you don't have a medical background, you have no business working as a CRA.

Totally agree, Sandy. I hate cleaning up after the new graduate CRA's floating in from a CRO.

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Linda in San Antonio, Texas

70 months ago

Unk in San Mateo, California thanks for the information. I will look into it.

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unknown in Bostic, North Carolina

70 months ago

These comments about "all CRAs should be medically trained" are ridiculous and a waste of time and deserve to be put on someone's wish list and then forgotten. The arrogant, short-sighted people making these comments apparently have their hands in all the pharma companies' and CROs' budgets. Why not let everyone know that, despite their medical background, the companies should meet these highly-trained individuals' salary demands to make everyones' lives easier? All hot air.

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danielasalazar in Santiago, Chile

69 months ago

HI! I come from Chile where this industry is starting to grow therefore you have a lot opportunities as CRA, the problem is that many of these companies are news in the country and you do not have a background or information that allows to you take the best decision.
In this moment I received I good proposal from a CRO starting with P (not Parexel,PPD or PRA but also with 3 letters)..and listening your experience with the P company... I feel very scared!! This company comes from the eastern Europe,from the "vodka land" ...and I really never heard about them before... so please find enclosed my e-mail to get more information.

Bests,

Daniela
humoafoco@hotmail.com

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Tonero in Long Island, New York

68 months ago

Jay Chantlos in Tampa, Florida said: Dear anonymous clinical worker ,

I am sorry to hear that you are no longer with your most recent company but from what I have heard in the industry that can be viewed as a positive thing. If you are interested in exclusive monitoring opportunities with TOP pharmaceutical companies please let me know.

Jay Chantlos
Market Manager
Kforce Clinical Research
jchantlos@kforce.com

Hi Jay,
I'm a medical student and I will be graduating in April this year. I have always been interested in clinical research. I initially desired to conduct trials as an MD, however due to certain (family-related) commitments, I have decided not to go into a residency program.

I would appreciate it if you could clarify my prospects for obtaining a CRA position. My main concern is how my background is or could be viewed by CRO/Pharm recruiters. Is it overly qualified? In addition, I don't have actual CRA experience, however I was a CRC(sub-contractor)for NASA for 6 months prior to going to med school. Could my prior CRC experience combined with my MD degree be viewed favorably enough to get me an interview?

Finally, is it worth it to go through a CRO derived CRA training program (6 months of classroom and 6 month of in-house/on-site internship) where they (CRO) claim that I will be offered "market-rate" compensation upon completion.

Or would it be wiser to pay a 4th of the cost of that program in obtaining a mere "certificate of completion" from an on-line course as a supplement to my background and enhance my resume to reflect my medcial/clinical knowlege and interpersonal skills to show that I would make an excellent and competent monitor because "it takes one ['doctor'] to know one"? Please, your thoughts would be very much appreciated as it will help me plan a course of action. Thanks very much.

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PP in Milford, Connecticut

68 months ago

Hi Unk,

Thanks for your feedback. I was wondering if you or anyone reading have any feedback on Paragon Biomedical. They are a CRO. They are headquartered in California but they have regional home based positions nationwide. They are also global. I have submitted my resume to them and I have an interview scheduled for next week. They seem very impressive.

Also, I know someone who works for Quintiles like youself as a Study Manager and she is very happy. I submitted my resume to them but Quintiles currently has a hiring freeze.

PP

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Unk in San Mateo, California

68 months ago

Dear PP in Milford:

I have a friend who is a CRA who works for Paragon out in LA. She is happy working there. She used to work for Quintiles. She has told me when comparing companies there are pros and cons. Paragon is smaller, offers less benefits, the technology they provide is not as high tech as Quintiles, the per diem is more, but she has less of a budget on hotels and airfare. Overall what she likes best is that she is truly regional right now. However, she is aware it may not always be that way but in California it is an important plus.

I have heard good things about Paragon and I am a beloved employee of Quintiles (I love Quintiles and will not go anywhere else and I used to work for Pharma!). :D

You are correct, the Q has a freezer on hiring right now.

Happy Q employee.

Good Luck.

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PP in Milford, Connecticut

68 months ago

Hi Unk,

Thanks for your feedback. I would like to speak with you some more. Could you please e-mail me at cocoawalk123@yahoo.com if you do not mind. Thanks so much.

Milford

Unk in San Mateo, California said: Dear PP in Milford:

I have a friend who is a CRA who works for Paragon out in LA. She is happy working there. She used to work for Quintiles. She has told me when comparing companies there are pros and cons. Paragon is smaller, offers less benefits, the technology they provide is not as high tech as Quintiles, the per diem is more, but she has less of a budget on hotels and airfare. Overall what she likes best is that she is truly regional right now. However, she is aware it may not always be that way but in California it is an important plus.

I have heard good things about Paragon and I am a beloved employee of Quintiles (I love Quintiles and will not go anywhere else and I used to work for Pharma!). :D

You are correct, the Q has a freezer on hiring right now.

Happy Q employee.

Good Luck.

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PP in Milford, Connecticut

68 months ago

Hi Unk,

Please let me know if you wouldn't mind e-mailing me directly. If you do not want to then I can understand and we can continue the discussion here. I look forward to hearing from you either way.

PP
Milford.

PP in Milford, Connecticut said: Hi Unk,

Thanks for your feedback. I would like to speak with you some more. Could you please e-mail me at cocoawalk123@yahoo.com if you do not mind. Thanks so much.

Milford

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Federica McDonald in Irvine, California

68 months ago

Unk in San Mateo, California said: Dear PP in Milford:

I have a friend who is a CRA who works for Paragon out in LA. She is happy working there. She used to work for Quintiles. She has told me when comparing companies there are pros and cons. Paragon is smaller, offers less benefits, the technology they provide is not as high tech as Quintiles, the per diem is more, but she has less of a budget on hotels and airfare. Overall what she likes best is that she is truly regional right now. However, she is aware it may not always be that way but in California it is an important plus.

I have heard good things about Paragon and I am a beloved employee of Quintiles (I love Quintiles and will not go anywhere else and I used to work for Pharma!). :D

You are correct, the Q has a freezer on hiring right now.

Happy Q employee.

Good Luck.

I used to work for Paragon, they are a good company.

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Anonymous in Sunnyvale, California

68 months ago

Hi,

I am an experienced CRA in the bay area and currently looking for an opportunity. The company I worked for had lay-off's recently. Can you let me know if your CRO is hiring!

Thanks!

Unk in San Mateo, California said: Sandy:

Please do not put out there the stereotype that all "CRO CRAs" are not medically trained. I am an MSN prepared nurse and was a Study Coordinator 5 years prior to monitoring. I also worked for a major pharmaceutical company for several years and decided to move a large global CRO because it offered better work life balances, the corporate culture was absoutely a dream (compared to the unspoken rules of pharma's corp. culture), for the variety of studies I get to work on, and for the awesome upward mobility. These kind of "stereotypes" are so unnecessary! You comment "If you don't have a medical background, you have no business working as a CRA is so wrong. I know hundreds of CRAs that are and if there is something they do not know they ask. This industry is in dire need of more talented CRAs and to limit them to the requirement of having a medical background is so short sighted. I am an MSN prepared nurse and have see great leaders in our industry train these CRAs during protocol training... this is how it's done!

Love my CRO and will never work for pharma again.

Unk

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Unknown in Raleigh, North Carolina

68 months ago

TB in Palm Harbor, Florida said: Totally agree, Sandy. I hate cleaning up after the new graduate CRA's floating in from a CRO.

I totally agree. I have over 2 years experience as a CRA with over 12 years in data management. CRA's with no medical background have no business in the industry. As a CRA I, I had to cleaned up significant issues,especially the drug log that a senior clinical research associate make and trained CRA II with less skills. It is not necessary the less experienced CRA, but also the experience one that leaves mess. Those are the ones that sell their themselves in interview, stay for two year or before the project end and more on to the next company. Sometime promotion without the prosper skills. Well come to the CRO World.
Unknown in Raleigh, North Carolina

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Unknown in Raleigh, North Carolina

68 months ago

TB in Palm Harbor, Florida said: Totally agree, Sandy. I hate cleaning up after the new graduate CRA's floating in from a CRO.

I totally agree. I have over 2 years experience as a CRA with over 12 years in data management. CRA's with no medical background have no business in the industry. As a CRA I, I had to cleaned up significant issues,especially the drug log that a senior clinical research associate make and trained CRA II with less skills. It is not necessary the less experienced CRA, but also the experience one that leaves mess. Those are the ones that sell themselves in interviews, stay for two year or before the project end and more on to the next company. Sometime promotion without the having the skills. Well come to the CRO World.
Unknown in Raleigh, North Carolina

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SAM in Fort Myers, Florida

68 months ago

Quality Seeker, I understand your past frustration with the industry. As a past quality auditor I saw many issues at both sites and CROs. fortunately i was employed by a company that quality was important. After reading many of these blogs (in the site for the first time)I am wondering if the CRA role is something I am interested in undertaking as a second career. Will have to noodle on that one. Thanks for the information.

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Mokgatla in Pretoria, South Africa

67 months ago

Interesting comments about CRA life and work. I do agree with most of the comments on this blog. I am a CRA who has no family life. I am constantly on the road, very little rest hardly see my children. I literally spend time at airports and aeroplanes.

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a medical researcher in Colorado Springs, Colorado

67 months ago

It's not always about having the "medical" experience! I've worked with several nurses who go around bragging they have a "Master's" yet don't know one end of a body part from the other! They've trashed the paperwork that's supposed to be data and supposed to be enabling a cure for a disease! The longer these research people get away with doing this the longer a cure is being held! Now that's pretty scary! What's even scarier is that employers keep these people around just because they have "RN" after their names! Unbelievable!

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Weezy in Birmingham, Alabama

67 months ago

Nadia F in Spring, Texas said: Hello All, I was wondering if anyone has anything positive or negative to say about Quintiles. I have a face-to-face interview with them this week as a Regional CRA.Thank you, Nadia
Hi NadiaI have worked with Quintile monitors before as a CRC and have never heard anything negative about them, I have a phone interview for a CRA position with them and wonder if you had a phone interview first too and what kind of questions did they ask, also did you get the job?  Please email me at louiselmccall@yahoo.com

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Weezy in Birmingham, Alabama

67 months ago

Unk in San Mateo, California said: Dear PP in Milford:I have a friend who is a CRA who works for Paragon out in LA. She is happy working there. She used to work for Quintiles. She has told me when comparing companies there are pros and cons. Paragon is smaller, offers less benefits, the technology they provide is not as high tech as Quintiles, the per diem is more, but she has less of a budget on hotels and airfare. Overall what she likes best is that she is truly regional right now. However, she is aware it may not always be that way but in California it is an important plus.I have heard good things about Paragon and I am a beloved employee of Quintiles (I love Quintiles and will not go anywhere else and I used to work for Pharma!). :DYou are correct, the Q has a freezer on hiring right now.Happy Q employee.Good Luck.
Dear UnkI have a phone interview with Quintiles next week, I was wondering if you could give me any pointers for my interview and if you could remember some of the interview questions?  I have been trying to get a job with Quintiles for the last 5 years and I dont wnat to blow it!!  Please email me at louiselmccall@yahoo.com

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CRABLUES in California

67 months ago

The problem with working for some CROs is that the focus is not on quality data, nor is it on following FDA or protocol guidelines. The projects are severely under bid because they accept contracts from anyone! The CRAs have little or no training. I was a nurse for many years, and then took an 18 month on the job internship. I monitored sites 85% of my life, and the other 15% was spent making travel arrangements and writing reports. I absolutely agree that without a medical background, it is impossible to be a good CRA. I have been on site with many people who lacked medical training and therefore did not know an adverse event, or worse yet a serious adverse event! They can not recognize co-morbidities, and frankly do not know what they are looking at. These unfortunate souls are thrown to the wolves and expected to answer to project managers who also have no medical experience and therefore can not provide any guidance whatsoever! Yes, you will be fired if you rock the boat at all, and if you insist that the protocol be followed, or FDA guidelines be followed, you are blacklisted as not a team player = performance issues = they do not want you anymore. Walk away with pride. If you are right and you know you are right, then just go to another place. What else can you do? Always take the high road because in the end, these folks will be rounded up and on TV for their irresponsible practices. I have nothing against people who want promotions, but if you are promoted beyond your intelligence, either step down, or try an old military trick.... let the lesser officer save your butt by telling you how the work is really done, and what is really going on. I can so related to BURNED OUT in WA! I would have to say that I had no idea there were so many CROs that began with the letter P.

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Unk in San Mateo, California

67 months ago

Dear CRA Blues in California:

I highly disagree with you and I certainly do not know what CRO you were working with but that is not the case with the CRO I work for. QUALITY and SAFETY of subjects is of the utmost importance. It is sad that you have had such a bad experience at another CRO. I also disagree with your comments on CRAs who do not have a medical RN license. I know of many CRAs who do not and they are very well trained that do not have an RN License. I am an MSN with many years of training as a nurse and I can say this that they are doing a great job. Although there are some CRAs out there that are new, trained, but not well suited for this job. My company weeds out those who are not going to work out. I have noted that if the CRAs (who do not have RN licenses) are unsure of something they contact the Clinical Team Lead or the Medical Monitor. Sounds to me that you are bitter about your travel schedule and a lot of other things. Maybe its your performance that has been a problem and not others. My experience is if there is a problem I go straight to the clinical team lead and if not dealt with there I have a Line Manager I go to and it is always handled efficiently and expeditiously. Maybe you are working for the wrong company.

The CRA life is not easy, however I have to say I loved being a CRA. I would never go back to my old nursing career with the state health care is in. The job is a lot of travel but if you enjoy that then you have found the right career. Perhaps you have not found the right career for you.

PS There are many CRAs out there that do not have an RN license who are promoted because they have an excellent work ethic and have proven they can do the job. Is it possibly you were not promoted and you are bitter?

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CRABLUES in California

67 months ago

No, I am not bitter. Please go back and read the initial post from Burned Out in Spokane, WA. The CRO that starts with a P is not a good place to be. I have been doing this for many years, and have worked at good places and hated to leave and very bad places that I could not wait to get out of. I did not need a promotion since I am already a Senior Manager. No complaints about money, benefits or work life balance, however the shift to production vs perfection is a real problem. I am happy for you that you are so thrilled where you are. My therapeutic area is very complex but there are worldwide standards that are supposed to be followed. I love my career and I enjoy what I do. Having spent so many years on the road, I fully understand the pros and cons of that position. It is however a reality as the 483's and consent decrees illustrate, that not everyone out there is interested in a good job!

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Burned Out in Spokane, Washington

67 months ago

To Unk in San Mateo:

It is very well known that CRO quality of monitoring is bad and they have a relatively untrained staff. This problem continues and is getting worse. I would suggest that you take of your blinders and research the issue. I hope you don't wear those blinders while you are monitoring?

I am also disappointed about how agressive CRAs are with each other. Your comment about CRA Blues being "bitter" accomplished nothing but showed a disrespect for the views of CRA Blues. Competition amongest CRAs is one of the reasons why the job has not progressed into a valued occupation. We have not united and worked to help each other identify then remove the barriors to quality monitoring.

The other issue about training is something that needs to be discussed, identified, and resolved. Currently, the training provided by CROs is very bad and this includes PPD and Quintiles. The training from those so-called certification programs is atrocious. We wear so many hats and have to know many aspects of clinical research that it goes beyond just the medical/science knowledge and being able to read a medical record. It takes more than just knowing the "word" of regulations but also the "intent" behind regulations to make a good CRA. A good CRA needs to know and understand the data and how it is analyzed. I have seen many people with degrees in the medical field, such as RNs or MDs from other nations, fail because they cannot fit their medical knowledge into the regulatory process and they don't understand the data. So they overlook many significant medically important trends and safety issues. Why look at you - with a MSN degree you have failed at understanding the issues.

Being a good CRA also means being able to respect other people and resolve issues. You did not demonstrate this ability but instead elected to attack CRA Blues. Attacking others, is a true mark of a CRO trained monitor who is not willing to open up their eyes and see reality.

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Burned Out in Spokane, Washington

67 months ago

CRA Blues,

I really appreciate your comments and I fully understand what you mean about the ethical obligations. I have been again out-of-work since August 2008. I observed serious study misconduct because Eli Lilly failed to train the site staff adequately and the study was not being conduct according to the very confusing protocol. Eli Lilly fired me because I would not jump on their bandwagon of blaming the principal investigator and study coordinator as the cause of all the problems. Actually, the problem came from untrained Eli Lilly Project Managers and a very poorly written protocol.

Anyways there are many of us that have the CRA blues and are depressed, angry, and very disappointed in the fact that harmful drugs are increasingly making it to the market place. (That is also known as a fact which can be researched) Despite the response from another blogger - some of us see very clearly and understand the larger issues.

I can only believe that changes will be coming and that CRA abuse will stop. Please go to the FDA website and search the term CTTI. CTTI stands for Clinical Trials Transformation Initiative. Contact the FDA CTTI Coordinator and ask her how you can get involved with the Improvement of the Quality of Monitoring project. The initiative needs to hear from CRAs like you who know the hardships that we face with too much work, too much travel, underpaid, efficency ratings and productions style work, and the inability to report study misconduct or subject harm without getting fired. I understand CRA Blues so ignore the so-called MSN educated CRA who made the problems that you are facing look like all your fault. Perhaps being able to voice your opinion and share your experiences with the CTTI will remove a tiny amount of helplessness that you feel by providing an outlet that may result in improvements for CRAs. Also, go to Medzilla and join the CRA forum. Take care - Burned Out

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LM in Birmingham, Alabama

67 months ago

Does anyone know of any companies hiring CRA's i Birmingham Al

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Unk in San Mateo, California

67 months ago

Dear Burned Out and CRA Blues:

My apologies to CRA Blues, I did not mean to be insensitive to your plight.
Firstly, I’d like to say there are many great people in this industry and you are incorrect in saying it is well known that CRO quality of monitoring is bad; that statement makes it sound as if all CROs suck, which is not the case. There are CROs in this industry that do superb monitoring and have a great focus on quality. I think there are CRAs/employees in all Pharmaceutical Companies and CROs that require additional training and that is the case in many industries. No one industry nor person is perfect not even the FDA.
While there are some individuals out there that require additional training that is the case with ANY job. I would also like to state I am not unsympathetic with CRA Blues. I hear what CRA Blues is trying to say, however my father used to tell me, "If you are not part of the solution you have no right to complain." I think we in the industry have all seen things that we shake our heads at and wonder how in the world... But those of us who truly love what we do, ensure safety of subjects and the quality of data, what are we doing to improve things? What are you doing to improve things? We don't have to do anything big or huge, but simply what we communicate to others is a start. Are we simply complaing or are we doing something about it? What can we do? What about volunteering to mentor a younger CRA who is not an RN? No, you cannot give them the training an RN gets but you can give them the resources you use. You can give them something more valuable, your knowledge that is based on “experience”. We as CRAs who want to make a difference what do we convey to other younger, less trained CRAs? Do we in our actions and our words communicate in a positive manner? That we are lucky to be in this industry or do we complain bitterly? Have you ever listened to someone complain, complain, complain, and have you ever thought, “Give it a rest”? We n

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Unk in San Mateo, California

67 months ago

My Comment above was truncated so here is the rest...

Have you ever listened to someone complain, complain, complain, and have you ever thought, “Give it a rest”? We need to communication in our actions and words POSITIVELY to affect other colleagues in a POSITIVE manner. I mentor other CRAs, that is my contribution. I am actively involved in local ACRP chapters and have been a past president. I speak at a variety of venues on training items. Ask yourselves, what can I do to make a positive impact? I have received so many comments from so many younger CRAs thanking me for the time I took to impart my years of "experience" and they stated they learned so much. This is where everyone can start; right where they work. Ask if you can be part of a quality committee, SOP committee, mentor program, training program, whatever.
One can either sit there and complain or do something. Yes, we need to ban together, but what is each one of us doing to make a positive impact.
My father was a great man with wise words and I’ll state them again, “If you are not part of the solution you have no right to complain.” Think about what you can give, your knowledge, and knowledge is power, empower others so they can empower others. Everyone can effect change through positive actions and communications.

UNK

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Donnalrn in Birmingham, Alabama

67 months ago

Jay, I am a RN with 29 years experience in acute care. I am extremely interested in getting into the clinical research field. I am getting so much conflicting information I'm not sure what I need to do. I first thought to get a CRA certification would be good but I'm not sure now. I keep seeing "experience" CRA job but the companies don't seem to be interested in training for entry level CRA yet there is much said about the demand being great. Why wouldn't companies not be willing to invest 90 days or so of training (internship even) in order to fill vacancy within their company? Any advice will be appreciated.

Jay Chantlos in Tampa, Florida said: Dear anonymous clinical worker ,

I am sorry to hear that you are no longer with your most recent company but from what I have heard in the industry that can be viewed as a positive thing. If you are interested in exclusive monitoring opportunities with TOP pharmaceutical companies please let me know.

Jay Chantlos
Market Manager
Kforce Clinical Research
jchantlos@kforce.com

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Donnalrn in Birmingham, Alabama

67 months ago

Does this include professionals that trying to get into the field of CRA? If so I would like to be a part of the experienced CRAs for mentoring. dlimbaugh@bellsouth.net

JCRA in Olympia, Washington said: With regards to your comment about a blog for CRA's, I wanted to offer something we are doing that is a bit different. I am the cofounder of a site called CRAlife.com. We are not recruiters, an agency, or CRO/sponsor. The whole purpose of the site is to create a private online community of CRA's. We launched two weeks ago and now have 200 members. It's free to CRA's and exclusive to CRA's. As membership grows, we will offer free services to CRA's, and pay for through advertising etc... It is invite only, which helps us to create the privacy we need. If any CRA is interested in checking us out, please send me an email at Jon@cralife.com.

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Nisha in Fairfax, Virginia

67 months ago

Hi well you said you hve time and can volunteer so i would like to ask u sth. I have a bachelors degree in Pharmacy from India and masters degree in Health service administration from U.S. I want to go into the CRAs. Do you think it will be easy or do u suggest something else better. I would appreciate for your reply in this regard.

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