Clinical Research Associate jobs are in high demand. CRA jobs pay well, are often home-based, and offer a relatively high degree of personal autonomy. It’s a job that offers a good mix of solo time as well as working with others, and it’s a job where you can really feel like your work matters, because you’re contributing to the safe development of new drugs that can improve lives. The CRA role hasn’t changed a great deal over the years, with the exception of the increasing adoption of electronic methods for collecting case reports. But the nature of CRA employment has changed and is continuing to shift as companies change the way they do business. This article will discuss the four most common CRA employment arrangements and make some predictions for the future.
- Direct employment by a pharmaceutical company.
Most people contemplating a career as a CRA probably envision themselves working directly for a pharmaceutical or biotech company as a full-time, salaried employee. Years ago, this was the most common employment situation for CRAs. Companies would design their own clinical trials and use their own employees and resources to conduct them. CRAs tend to like this kind of employment because of the perceived stability that comes from working for a big company and the generous salaries and benefits that were used in an attempt to ‘buy’ employee loyalty. On the downside, these CRAs were often specialists in a particular therapeutic area and didn’t get exposure to other kinds of clinical protocol, and are sometimes required to travel over a huge geographic region.
- Direct employment by a Contract Research Organization (CRO).
CROs got their start in the 1970s, and for many years they remained a pretty marginal part of the industry (you can watch a video about Quintile’s early beginnings here). During the early 2000s, things began to change. Big Pharma companies, under pressure from stockholders due to declining revenues, patent expirations and increased R&D costs, were encouraged to focus on their core competencies (drug discovery and marketing). At the same time, explosive growth in the biotech industry created companies that didn’t have the internal resources to carry out trials. Contract research organizations allowed companies to shift their clinical development activities out-of-house, streamline their operations and reduce their infrastructure costs. The CRO industry grew rapidly and now books annual revenues of ~$20 billion. Its biggest players (such as Quintiles, Covance, Icon, Kendle and Parexel) are international companies with offices worldwide, fully capable of managing massive global clinical trials. But smaller CROs have been successful too, marketing their services on the proposition of specialized expertise, flexibility, personalized service and reduced overhead. Clinical research associates at CROs often appreciate the opportunity to work on a variety of trials in different therapeutic areas and find it a great way to develop a broad range of experience. On the flip side, CROs can be a high-pressure environment, and some CRAs find working with different trial protocols confusing and frustrating. Many CROs deploy their workforces regionally, so that travel is limited to a reasonable geographic area. Salaries and benefits are usually quite good, although not quite as good as working directly for a pharmaceutical company. After ~2 years of experience, CRAs typically find it easy to find new employment opportunities if they aren’t happy. In the current economic situation, the global CROs may offer more stability than smaller, more local organizations.
- Self-employed, independent contracting.
Many CRAs aspire to the freedom of self-employment. Experienced field monitors are in high demand, and it has been relatively easy for those with proven skills and good references to set up their own businesses, picking up contracts from pharma companies or CROs. Independent contractors often charge $75 – $100 or more for their services, and can easily earn six figures or more each year. In addition, they can choose contracts that suit their lifestyle and travel preferences. However, independent consulting has its minuses as well. Independents must pay for their own benefits and vacation time. Many CRAs do not enjoy the work required to market their services, which is necessary to avoid long periods of “down time” between contracts. Some find that the burdens of running their own business on top of thier long days monitoring isn’t worth the increase in income. As companies become more sophisticated in the way they manage outsourcing, independents may find it harder to find opportunities on their own. Increasingly, companies find it easier and more efficient to sign a single contract with an outsourcing agency or CRO rather than managing stacks of separate contracts with independent consultants.
- Employment through an outsourcing agency.
The most recent development in clinical outsourcing has been the growth of specialized outsourcing agencies, which claim to offer the best of all possible solutions to both pharmaceutical sponsors and clinical professionals. Unlike a CRO, these clinical staffing agencies do not provide any consulting services; they simply provide human resources (often CRAs, but also trial assistants, coordinators, project managers and others) who can help a company carry out a clinical trial. Whereas CROs often provide a turnkey service, this model makes use of a companies existing knowledge base and infrastructure and gives them complete control over protocols and trial activities. The sponsor can flexibly expand or contract the size of the clinical force through a single master agreement. By acting as a go-between, the agency can provide CRAs with the flexibility of self-employment while taking over the challenge of finding new contracts. Agencies can usually pay CRAs more than they would make as a direct employee of a CRO or sponsor but not quite as much as they would make as a fully independent consultant. One of the largest agencies, and a pioneer in clinical outsourcing, is Kforce.
So, what does all this mean for a CRA or wannabe CRA? In the current economic climate it’s difficult to say with any certainty. But it’s clear that clinical development has undergone a number of shifts in strategy that have affected employment patterns over the past few decades, and it would behoove anyone in the sector to keep their eyes open if they hope to chart a clear path for their career. My best guess is that big CROs will be fighting with outsourcing agencies for dominance within the next few years but that CROs will continue to offer the best opportunities for entry-level career development.
Posted: February 11th, 2009 | Author: Headhunter | Filed under: Clinical research, Clinical Research Associates | Tags: career, clinical, clinical research associate, clinicalresearch, contract research organization, CRA, CRO, independent, outsourcing | 8 Comments »