One of the most common misperceptions about clinical research is that all clinical researchers work “at the bench.” That is, all researchers are scientists working in labs to develop new medicines. While that is certainly an important part of clinical research, it is far from the only role in the development of new treatments. In fact, one of the fastest growing clinical research careers isn’t in the lab at all, but rather in a managerial role, overseeing the overall research study.
With several thousand clinical trials taking place all over the world at any given time, it only makes sense that each trial must have someone in place to coordinate all the disparate elements of the process. Clinical operations, or clinical research administration, is a vital part of the clinical trial process in all phases, and ensures that trials run smoothly in accordance with all required protocols. Combining both the scientific aspects of clinical research with business management, clinical operations helps guide organizations and researchers toward developing news and exciting medical breakthroughs.
Why clinical operations is in demand
Clinical trials are complex, and include many moving parts, from subject recruitment to final FDA approval. As research expands on a global scale, and eCOA clinical trials and other technologies become more commonplace, that complexity only increases and requires a greater integration of both research and business principles and processes. Not to mention, developments within research best practices and techniques, changes to standards of patient care, and new approaches to diagnostics and therapeutics are leading to explosive growth within the field of clinical research overall — and the need for clinical research practitioners in all roles, both research and administrative.
Clinical operations roles run the gamut from administrative roles, which support day-to-day trial operations to clinical research directors, who oversee the entire trial and have responsibility for every aspect of the research. Other common roles in include clinical research associates, who travel between research sites to ensure that all trial sites are adhering to protocols, as well as clinical study or project managers who manage teams on a regional or local level. Experience in clinical operations also prepares individuals to work as medical writers, and serve on Institutional Review Boards.
Regardless of the specific job title, though, clinical operations is an in-demand specialty. The Bureau of Labor Statistics notes that jobs in medical management, which includes clinical research management, are expected to grow much faster than average, at 17 percent, by 2024. In the UK, CKClinical, a clinical research recruitment agency, noted that clinical research position postings increased by 50 percent in 2015 alone. As more pharmaceutical and biotechnology companies outsource their research, the number of positions in independent laboratories is likely to increase significantly, making this area a reasonable bet for anyone with research experience.
Working in clinical operations
Clinical operations work is multi-faceted, required individuals to have knowledge and experience in both research and business. Perhaps one of the most important skills, though, is communication, as these roles typically require one to liaise with other leaders in the drug development process. Other important skills include organization, experience in clinical research throughout all phases of studies, and experience in multiple therapies.
Most people who work in clinical research operations come from a clinical research or health-related background, such as pharmacy. Despite rapid growth in the field, there are still very few academic programs specifically devoted to clinical operations. That being said, many operations professionals begin with a degree in the life sciences or another science-related field and a job as a clinical trial assistant, as a means of getting experience. That experience is crucial to earning the Certified Clinical Research Associate (CCRA) credential from the Academy of Clinical Research Professionals, which indicates that you have met the professional standards of the organization and are qualified to serve in a research leadership role.
The payoff to a career in clinical operations is, of course, the satisfaction that comes with being involved in potentially lifesaving research, but the pay is also competitive. A clinical research director can earn well over $200,000 per year, while managerial positions tend to pay within the $100,000 to $130,000 range.
The field of clinical research expands well beyond actually working at the bench to test and analyze compounds and data. Without research operations, many studies would fail to even get off the ground. As you consider your clinical research career or your next move, don’t rule out an operations role, as it’s an exciting and in-demand option.
Jackie Roberson is a content coordinator with Seek Visibility.
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