What is a Clinical Trial Specialist?

What does a clinical trial specialist do?

A clinical trial specialist is an individual (usually a professional with extensive experience in the industry) that offers operational support during clinical trials. This role is not strictly defined, and similar functions may be fulfilled by positions such as a clinical research coordinator. The job of a clinical trial specialist can vary widely, and might include reviewing SOPs, assessing adherence to regulatory standards and requirements, identifying issues with the execution of the trial, and providing assistance in improving process efficiency and workflows.¹

Other responsibilities of a clinical trial specialist could include: helping to prepare training material; working with trial clinicians to prepare and share clinical reports and IND safety letters; coordinating meetings; collecting and managing clinical trial documentation; serving as liaison between CROs, sponsors, and sites to ensure clinical trials are on track with budget and timelines; and other activities that sponsors or clinical trial managers may need specialized assistance with for efficient clinical trial conduct.

Qualifications: Who can become a clinical trial specialist (CTS)?

As the position of clinical trial specialist is not one of the common professions in clinical research, it is not clearly defined. A clinical trial specialist, as the name implies, will likely need specialized knowledge - either for the entire scope of clinical research or for specific functions, potentially acting as a type of clinical trial consultant for CROs and/or sponsors. If you are looking to become a clinical trial specialist, higher education will likely be beneficial, but experience in the industry is likely to be the most important requirement.

Obtaining some type of professional certification, such as that from the Association of Clinical Research Professionals (ACRP Certified Professional), can serve to demonstrate your knowledge and expertise and improve your prospects when seeking employment. This position is more likely than others in clinical research to be tailored to the specific needs of the organization hiring or the current trial(s) they are working on, so your best bet is to simply search for job postings and see where your skills may match!

What expertise and knowledge should a CTS have?

For a clinical trial specialist, extensive knowledge about the following broad aspects of clinical research is likely a prerequisite:²

• Understanding of scientific terminology and medical and technical concepts
• Thorough understanding of the process of drug development, including all phases of clinical trials
• Strong computer and data management skills
• Familiarity with Good Clinical Practice (GCP), FDA guidelines, and any applicable local/regional regulations
• Organization, teamwork, and time management capabilities are likely to be important when collaborating with diverse study teams and communicating between sponsors, sites, and researchers

Keep in mind that this list is not extensive, and in general, experience in any aspect of clinical research will boost your qualifications and authority in that topic.

What can a clinical trial specialist offer CROs and sponsors?

Often, clinical trials require specialized expertise, for example in the case of rare disease trials or forays into new medical areas. In other cases, sites or sponsors may need general assistance with setting up trials or managing operations. A clinical trial specialist (or a “clinical trial expert”) may be able to bring this specialized knowledge to the team.³

A specialist could be called upon to help with ensuring and demonstrating regulatory and ethics compliance, patent outreach and recruitment, monitoring, or reporting research findings to the sponsor. They might have specific knowledge about budget preparation and management, or in clinical data management. As the hiring organization, it’s up to you to decide what area(s) you need help with.

Clinical trial specialist training/courses

If you are interested in taking a clinical trial specialist training course, there are a few formal training programs that can help you gather specific skills and accreditation. The Society of Clinical Research Associates offers individuals the Certified Clinical Research Professionals certification if they have a relevant degree in clinical research or the required amount of experience in the field. This certification can help make your skills and expertise more transparent to potential employers.

There are various degrees and courses designed to equip students with the skills for a career in clinical research, such as Harvard Medical School’s Foundation of Clinical Research⁵, courses by the European Centre for Clinical Research Training⁶, and a number of different online courses from sites like Coursera which list programs from universities like Johns Hopkins, Vanderbilt University, and Yale University.

Clinical research associate job outlook

With the clinical research industry expanding in general amidst the adoption of new technologies and uses of data, there is currently a significant demand for qualified clinical research professionals. Further, salaries for clinical research associates (one example of a position in clinical research) have risen by as much as 15% over the last five years.⁸ Employment opportunities are projected to grow by 6% between 2018 and 2028. As mentioned, clinical trial specialist is not necessarily strictly defined, but experts in various aspects of trial operations are likely to also be in high demand, especially those with experience in specialized or emerging topics such as decentralized and remote trials, eClinical solutions, and personalized medicine.

Where to look for clinical trial specialist jobs

If you are looking for work as a clinical trial specialist, check directly with local pharmaceutical and biotech firms, which may offer suitable openings. In addition, you can search for “clinical trial specialist” or related positions like “clinical trial expert” or “clinical research coordinator” on job boards like Indeed, Monster, and ZipRecruiter, and on LinkedIn.

Conclusion

The demand for clinical research professionals is projected to grow in the coming years, thanks in part to new developments and possibilities in clinical trial designs and methods. To become a valuable specialist or expert in clinical research - either in general or in a specific aspect of trial design or operations - it is a good idea to simply start gaining experience. Professional development courses and certifications can help you on this journey, and at the end of the day, it’s about providing a service that sponsors and CROs need assistance with for getting new therapies to market to help patients.