10 things to look for in an academic Regulatory Affairs program

Signing up for a formal academic program is one way to put yourself on the fast track to a career in pharmaceutical regulatory affairs.

The Regulatory Affairs Professionals Society (RAPS) is a great clearinghouse of information.  If you’re interested in a career in regulatory affairs, it’s a great place to learn more about the role.  Membership isn’t cheap ($185), but it is significantly discounted for current students, and includes a subscription to Regulatory Focus magazine, discounts on educational programs, and access to networking opportunities. RAPS offers online courses that may help give you the knowledge you need to land an entry-level role and maintains a list of degree and certificate programs offered at academic institutions worldwide.

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Posted: January 13th, 2009 | Author: | Filed under: Industry associations, Regulatory affairs, Training | Tags: , , , , | 1 Comment »

Free online training course in ICH-GCP Good Clinical Practice

[Update 2011: Unfortunately the MIT e-learning site appears to be out of service. However I have been able to find these courses hosted at a new location.  Enjoy them here.]

A thorough knowledge of good clinical practice is essential for landing a job as a clinical research associate, assistant, or coordinator.

Instead of paying a lot for an online ICH-GCP training program, you can learn what you need for free from these video seminars.  The site provides a series of lectures covering various aspects of the GCP guidelines.  It was designed to train physicians in South America and it’s affiliated with Pfizer and MIT, so you can trust what they tell you.  The only bad thing about it is that you’ll need to install RealPlayer (or the Real Alternative codec pack).

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Posted: January 10th, 2009 | Author: | Filed under: Clinical research, Education, ICH-GCP, Resources, Training | Tags: , , , , , , | 83 Comments »

Watch out for scams in clinical research training programs

This is a subject that really makes me angry.  If you’re reading this site, it’s probably because you are anxious and hopeful, perhaps even desperate to find your first job in the pharmaceutical industry.  Unfortunately, there are a lot of people out there who are willing to prey on that desperation and take advantage of job-seekers.

A common way to do this is to offer ‘training programs’ of dubious value, usually offered online at a cost ranging from hundreds to thousands of dollars.  I’m aware of a number of these courses related to specifically clinical research and so-called ‘CRA training’. These courses will provide you with some information about ICH-GCP (which you could have found online for free), give you some online ‘exams’ (which you can often retake as often as you like) and in the end, give you a ‘certificate’ that you can print out and proudly reference in your resume.  What you don’t know is that industry recruiters are well aware of these scam companies, and the only thing that these certifications will indicate is that you were gullible enough to be taken in by a con artist — probably not the impression you wanted to make!

The most disgusting of these scam companies has created a whole empire of sham companies and organizations, building a web to lure you in.  They have a phony recruiting company, a phony industry association, and several phony ‘biotech companies’ and CROs.  These sham organizations will post fake job advertisements promising entry-level opportunities in clinical research.  When you apply, you’ll get an email telling you that sorry, you aren’t qualified, but you should consider taking a online training program, which they’ll happily refer you to.  If you’re ‘lucky’, you may even be told that you qualify for a special ‘scholarship’, offered by the phony industry association.

I don’t know why the guy behind this scam hasn’t been busted and hauled off to prison.  He’s probably scammed hundreds of thousands, if not millions of dollars out of desperate job seekers, many of them new immigrants, over the years.

Why aren’t more people aware of this scam?  Well, part of it is that the head of this operation seems to be litigious.  Many discussions about Clinical Research Training programs over at Indeed.com refer to the program, but critical comments are mysteriously removed after the ‘CEO’ of this company posts to ‘respond to his critics’.

If you read enough of these forums, you’ll find that a lot of people are taking these courses, and many of them will even recommend them.  Some of these sound like shills to me… if you’ve created a phony training program, creating phony supporters isn’t that much more difficult.  Others sound like genuine people who don’t want to admit that they’ve invested more than $1000 in a program that won’t help them get where they want to go.

I am not going to directly link to the fraudulent sites in this post because I can’t afford to be sued.  But I will link you to a forum where braver souls than I are discussing this scam.

So, if you are still set on getting some training to help you land that first pharma job, how can you stay safe and avoid getting scammed?

  1.  Avoid online courses if possible. If you must go this route, ensure that the course is offered by a legitimate organization, like an accredited university or a government agency. In-class training is almost always more valuable, especially if it includes a co-op or other hands-on element.
  2. Do your research! Use the power of the internet to search for discussions about the program you’re considering. Be extremely skeptical when reading positive reviews and pay close attention to any negative comments being made.
  3. Ask the experts. Try to speak to people who are actually working in the industry to find out what training programs they recommend. Check out the websites for professional association, and see which programs they recommend.  For clinical research, you should check out the Association for Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA).

Of course, clinical research is not the only area where scam courses and certifications exist. I am also aware of some shady sites related to Medical Science Liaison training. Basically, any career path that is in high demand by job seekers provides an opportunity for con artists to take your hard-earned cash.  Be careful out there.


Posted: January 10th, 2009 | Author: | Filed under: Clinical research, Clinical Research Associates, Education, Medical Science Liaisons, Training | Tags: , , , , , , , , , , | 5 Comments »