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Alternative Careers for Lawyers: Spotlight on the Contract Specialist Role in the CRO Industry

By L. Collin Cooper

When I graduated from law school, I struggled like most young lawyers to find suitable work in the legal profession. For several months, I juggled document review projects with pro bono work until I found an opportunity to work for a large national firm as part of their smoking and health litigation team. Though I was working as an attorney contractor, I shared the same assignments as the firm’s staff attorneys, which gave me a good idea of what kind of workload was expected in a firm setting. After hours, weeks and months of trials, I decided that the litigation lifestyle was not for me. I therefore sought out alternatives to a litigation practice. In my search, what I found was a huge market for attorneys in the Clinical Research Organization (CRO) industry.

Honestly, when I ran across job postings at several competing CROs, I had never heard of the industry and had no idea what I was signing up for. Sure, I knew about clinical research, but I had assumed, incorrectly, that pharmaceutical companies were doing this research completely on their own. I quickly learned, however, that this was not the case. So, how does a law license fit into clinical research? The answer is a straightforward one — contract drafting, review and negotiation. Indeed, attorneys are consistently hired in “Contract Specialist” roles to draft, negotiate and execute contracts and budgets between international pharmaceutical companies and their investigational sites for clinical trials. This opened up a whole new legal market for me that I didn’t even know existed — a market with great growth potential and in-house corporate experience.

What is an average day like as a Contract Specialist in the CRO industry? The answer is: It depends. Just like a traditional law practice, work comes in waves, some of which are larger than others. Generally, though, you will be working with about 75 contracts at a time. The Contract Specialist drafts and finalizes contract language for each individual clinical trial, based on client input and preferences, institutional SOPs, domestic and international regulatory requirements, and best practices. Once the contract language is finalized and sent to the various sites for review, the negotiation process begins, which often involves extensive redlines and revisions of important contract provisions. Common areas of negotiation include intellectual property, indemnification, insurance, termination, publication and breach — just to name a few. Depending on the nature of the trial and who is conducting it, employment law and basic tort principles also come into consideration during the drafting and negotiation process. Therefore, as you can see, knowledge of various areas of law and practice are invaluable in this position.

Further, the Contract Specialist is also responsible for negotiating the budget for each site involved in the clinical trial. For most attorneys in this role, there is often a pretty steep learning curve here because the budget consists of a great deal of medical terminology and procedures. In fact, the budget breaks down procedures performed, based upon the trial’s protocol, and pairs each procedure with its respective fair market value cost. As the specialist, the participating site expects you to have an intelligent conversation about each of these procedures and negotiate a reasonable fee. This can be challenging for attorneys because it requires a working knowledge of medical terminology and procedures that can oftentimes be completely foreign to them.

How is a Contract Specialist able to approve all of these language revisions and costs during the negotiation process on behalf of the client? The client provides the specialist with parameters that they are willing to accept, very much like a settlement agreement. If a site’s request falls outside of these negotiation parameters in either the contract or the budget, the specialist must go back to the client and share the site’s demands. If the parties are at an impasse and cannot reach an agreement, the site does not participate in the study. If, on the other hand, an agreement can be reached by both parties on the contract and the budget, the contract can be signed, sealed and delivered.

It’s hard to wrap up a job description in a couple of paragraphs, and each contract, budget and clinical trial is unique; however, one can see that while the work is not like a traditional law practice, there are several aspects of the law that come into play on a daily basis. Working in close proximity to corporate counsel, as well as other attorneys in the Contract Specialist role, there is always a sounding board available when a complicated issue arises during particularly complex negotiations with larger sites, such as major universities or hospital networks. Further, CROs are generally global, so while you’re working predominantly on North American trials, there are also opportunities to work with attorneys and other CRO employees across the globe.

Now that the job description is out of the way, let’s talk about some of the benefits. For most employees in the CRO industry, the most important aspect is flexibility. The CRO industry is quite large, but as a general rule, most CROs do allow their specialists to work from home at least once a week. Even if you’re not working from home, it is generally expected that you only work 40 hours a week. While there are instances that require working over the standard 40 hours, they generally do not come up too often. This flexibility allows for more bar involvement, professional development and work-life balance, which for most young lawyers is a huge benefit. Finally, it’s important to note that Contract Specialist roles are not limited to the CRO industry. Indeed, just about every corporation has a Contract Specialist or Contract Manager, which performs the same duties for different industries. Truly, the opportunities are endless for any attorney that wants to try an alternative to the traditional practice of law.

L. Collin Cooper is a Senior Contract Specialist for Pharmaceutical Product Development, Inc. in their RTP office. He is Vice-Director of Diversity for the ABA YLD, Chair of the NCBA YLD Meetings and Conventions Committee, and Chair of the NCBA YLD Subcommittee on LGBT Issues.