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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What is a Clinical Research Associate (CRA) job all about?

Many people trying to obtain their first job in the pharmaceutical industry have a particular role in mind: the Clinical Research Associate, or CRA. These positions are seen as desirable because they typically offer relatively high salaries, a lot of independence, and are frequently home-based. In this post, I’m going to discuss the Clinical Research Associate’s role in detail: what do CRAs actually do? How does one obtain a CRA job? And what are the long-term career prospects for a new CRA?

As the name suggests, a Clinical Research Associates’s role in drug development begins at the clinical research stage, which is the point when human testing begins. CRAs may be involved with Phase I, II, III, or IV (post-marketing) clinical trials. A CRA’s main responsibility is to monitor clinical trials (and in fact some companies refer to CRAs as clinical research monitors). A CRA will travel to the clinical sites where trials are being conducted to ensure that all of the activity relating to the trial is in compliance with the protocol and ICH-GCP (Good Clinical Practice) guidelines. This may include reviewing the way patients are enrolled, to ensure that they meet the inclusion criteria; checking that clinical trial supplies are stored and dispensed appropriately; and reviewing Case Report Forms (CRFs) to ensure that they have been filled out correctly. In many ways, the CRA’s job is one of quality control, and many of the best CRAs pride themselves on having an extremely detail-oriented, “checklist mentality”. Of course, sometimes a site visit will reveal problems, and at that point the CRA must work with the staff on site to resolve outstanding issues. This can sometimes require a lot of charm and good negotiation skills!

Clinical Research Associates are frequently home-based, which is one reason that many people see this role as desirable, but this must be balanced against the fact that CRAs spend a great deal of time away from home. A CRA will typically be responsible for 5-10 different clinical sites, and will visit each one several to many times during a trial at a frequency determined by the protocol. This means that many CRAs are constantly on the road, and can expect to be away from home 60-80% of the time. Those working in urban centres may be able to drive to their sites, but regional CRAs must often fly to more distant locations. Many CRAs find the frequent travel exhausting after a few years of experience.

Historically, the major pharmaceutical companies that sponsor drug trials have been the largest employers of Clinical Research Associates, but this is beginning to change. Increasingly, these companies are outsourcing the operational aspects of the clinical trial process. Contract research organizations (CROs) such as Quintiles, Kendle, and ICON carry out trial activities on behalf of the sponsors. As a result, these days there are many more CRA jobs available with CROs than there are directly available with pharmaceutical companies. Many experienced CRAs choose to work independently, as self-employed contractors, working for a sponsor or CRO for the duration of a trial.

Working as a CRA for a Contract Research Organization can be different than working directly for a sponsor. In this position, CRAs often gain experience in many different therapeutic areas and work with many different protocols, which can be valuable for career development. However, they may also be required to monitor several different trials at the same time, which can be stressful. In contrast, CRAs working directly for sponsors sometimes complain because they are asked to monitor sites over much larger geographic areas, which can increase the amount of time they are away from their homes and families.

The Clinical Research Associate marketplace has been very competitive. Because CRAs are very much in demand, and their role is virtually identical in every company, it is easy for them to change jobs. CRAs are frequent targets of headhunters. As a result, companies have offered high salaries and excellent benefits in an attempt to buy employee loyalty. The pharmaceutical companies have typically offered higher salaries than CROs, but the shift in the marketplace towards outsourcing may be changing the dynamics of CRA compensation. Currently, a qualified CRA with less than 2 years of experience might reasonably expect to earn a base salary of about $60,000 and will see their salary potential grow quickly. It is not unusual to see CRAs with 3 years of experience earning in excess of $85,000. CRA compensation frequently also includes a company car and a competitive bonus structure. A CRA’s salary will normally max out at about $95,000. CRAs who go into business for themselves as self-employed contractors typically bill their services at $65-$100 per hour.

Many CRAs greatly enjoy their jobs and are happy to remain as clinical research monitors for their entire careers. Those who are looking for career development will typically move towards project management, becoming responsible for organizing a team of CRAs and managing operational aspects of trials. This in turn can lead towards senior roles in Clinical Operations.

To be hired as a Clinical Research Associate these days, an individual normally must have a degree in health sciences or life sciences. Many companies prefer to hire people with a Nursing background because of their familiarity with clinical settings. A very strong knowledge of ICH-GCP guidelines is essential. In terms of personality, a successful CRA must balance strong people skills with a very detail-oriented checklist mentality. It may be easier to get your foot in the door by starting as a clinical research assistant, or clinical trial associate instead. I’ll talk about this role in more detail in a future article.

Because CRA jobs are in demand, many courses and programs have appeared claiming to offer training that will help new job-seekers to obtain them. A number of colleges now offer post-graduate programs in clinical research that are respected by the industry; these frequently include co-op opportunities that give students real, on-the-job experience in clinical monitoring. In contrast, there are also many online courses and less reputable programs that will take students’ money, offer cursory training in ICH-GCP, and give graduates a certificate that is nearly worthless on the job market. One notorious company bills itself as a CRO, posts jobs online, and then steers applicants towards its expensive ‘training program’.  Unfortunately, having this company’s certificate listed on your resume is evidence of poor judgement, not good clinical training. Before spending any money on training programs, it’s important to do extensive research to ensure that you’re not getting ripped off.