CRA training: How NOT to conduct a site visit

Here’s an amusing look at a day in the life of a CRA (Clinical Research Associate) on a site visit. This video is a parody, but it does give you a sense of what site visits are all about.

A CRA may spend 60-80% of their time on the road conducting these visits.  Their job is to monitor the conduct of clinical trials, ensuring that research sites are enrolling patients and carrying out the trial correctly, following both the trial protocol and ICH-GCP conduct guidelines. They review a lot of documentation, check site supplies and generally watch out for problems.

When there are problems, a CRA needs to help get the clinical site staff back on the right track, and so they need to have excellent communication and negotiation skills.  It can take a lot of diplomacy to get clinical investigators and their staff to change the way they do things in a busy clinic!

The sound in the embedded clip isn’t synchronized quite right.  You can see a higher-quality version at the ResearchPoint site.  They are the CRO (Contract Research Organization) that created the video.

You can read more about what a CRA job is all about in this earlier article.


Posted: January 27th, 2009 | Author: | Filed under: Clinical research, Clinical Research Associates, Fun | Tags: , , , , | No Comments »

How much does a clinical research associate earn?

How much does a CRA earn?

Clinical Research Associate jobs are in high demand, partly because many people think that becoming a CRA is a career pathway that will help them make money fast.

Are they right?

Applied Clinical Trials, a trade magazine for the clinical development sector, recently published its 2008 salary survey, which includes salary information for clinical research associates as well as other clinical careers.

According to the survey, independent CRAs earn more than anyone else in the industry — $115K on average — although it’s worth noting that as independents, they have to pay for their own benefits and the costs of marketing their services. Of course, there can be tax advantages to running your own business as well.

The mean salary for CRAs who weren’t self-employed was $76K.

You can read more about the survey at the Applied Clinical Trials website.


Posted: January 16th, 2009 | Author: | Filed under: Clinical Research Associates | Tags: , , | 1 Comment »

Review: Career Opportunities in Biotechnology and Drug Development

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Here’s another great resource for your pharmaceutical job search: Career Opportunities in Biotechnology and Drug Development, by Toby Freedman.

Freedman has put together a solid resource for finding jobs and developing your career in the biotechnology and pharmaceutical industry. At 409 hardcover pages, this isn’t the kind of book you can slip in a pocket to browse on the subway — it’s a comprehensive guide that I could see being an invaluable aide to finding your first job in the biotech industry.

Early chapters on resume writing and interview techniques, including informational interviewing, are brief but well-written and useful. If you’ve read a lot of career guides, these chapters probably aren’t going to teach you anything you haven’t heard before.  The real meat of this book is the industry-specific information that follows.

In an excellent overview chapter, Freedman explains the breadth of the industry, and summarizes the different product development pathways followed by therapeutic, nontherapeutic, and medical device companies.

Next, individual chapters, each about 20 pages long, cover a wide range of career pathways: drug discovery, preclinical research, project management, clinical development, medical affairs, regulatory affairs, quality assurance and quality control, operations, product development, business development, sales, marketing, and corporate communications. Chapters on executive management, legal affairs, finance, management consulting and even recruiting round out this comprehensive guide.

Each chapter includes ‘snapshots’ of various roles and offers a thoughtful analysis of both the positive and negative aspects of a given job.  For example, in clinical development, Freedman notes that “Original and applied clinical research is exciting.  Outcomes are unknown until trials are completed, and each trial is unique. Your work is close to the market”, but “There is frequent pressure to meet constantly looming deadlines, and the objectives often seem to be ‘too much, too soon, with too little'”. When you’re just starting out, and trying to decide what path to follow, knowing the downside of a job can be very useful information.

Naturally, salaries and compensation are a matter for discussion, as is the potential for career development, and a look at how future trends might influence job security for each role is useful in today’s economic times.

Perhaps most usefully for job seekers, Freedman clearly lays out job requirements and typical pathways into the role, and offers tips that could be helpful for getting one’s foot in the door.  Descriptions of what it takes to excel in a role, and qualities common to good candidates are also helpful.

This guide isn’t cheap, and it isn’t very portable — but if you are looking for a career in the pharmaceutical and biotech sector, this book should be at your side.


Posted: January 14th, 2009 | Author: | Filed under: Clinical research, Interviewing, Marketing, Medical Science Liaisons, Preclinical R&D, Regulatory affairs, Resources, Resumes & CVs | Tags: , , , , | No Comments »

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).

Read the rest of this entry »


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: , , , , , , , , , , | 6 Comments »