A clinical trials administrator (CTA) primarily manages the administrative aspects of a number of clinical trials, at every stage of the process.
Clinical trials are controlled studies on the effects of medical treatment on both humans and animals. They monitor both the efficacy and potential health risks of new treatments, and must be carried out before a medicine can be sold.
CTAs play an essential role in the clinical trial process. Working with protocols (study plans), they prepare, distribute, track and file clinical trial documents. They may also deal with suspected unexpected serious adverse reaction (SUSAR) notifications, although in some companies there are specific SUSAR administrators who work alongside the CTAs.
The role of any clinical trials professional is extremely important, because medical treatment can save – and dramatically improve the quality of – people’s lives. Most will often work for pharmaceutical companies, which are organisations that produce and sell medical drugs. They may also work for biotechnology companies, which instead work with biological medicines. Some companies function as both pharmaceutical and biotechnology companies.
CTAs may also work for contract research organisations (CROs). These companies provide a range of services to pharmaceutical organisations wishing to outsource aspects of the research process. Their services include product development, data management and medical writing. See the Clinical Contract Research Association website for more information. The CTAs are office based, and spend the majority of the day working on a computer, using the Microsoft Suite as well as the company’s own software, therefore computer literacy is essential.
They may have to visit a dedicated filing and scanning room when dealing with documents. Countrywide or overseas travel is rarely necessary.
As well as working in an often large clinical trials team, CTAs work with staff at investigator sites, which are the hospitals that carry out the trial.
Because of the ethical issues associated with clinical trials, CTAs must adhere to ICH Good Clinical Practice (GCP) guidelines, which cover all aspects of a trial. These dictate that the results are credible and that the trial subjects are protected.
They must also work in accordance with Standard Operating Procedures (SOPs). These are written instructions that dictate how a process must be carried out. Every pharmaceutical company has its own SOPs.
As with many administrative jobs, there tend to be more female than male Clinical Trials Administrators.
In general the pharmaceutical industry pays well. CTA salaries range from £22,000 to £40,000 per year, depending on experience. Graduates can often demand higher salaries.
- Preparing essential clinical trial documents
- Tracking, distributing and filing documents when they are returned
- Re-ordering drugs on behalf of sites
- Maintaining the electronic Trial Master File (TMF)
- Preparing and sending study materials to investigator sites
- Attending study meetings and arranging investigator meeting arrangements
- Tracking and processing payments
- Raising purchase orders to pay investigator sites
- Supporting clinical research associates (CRAs) and perhaps visiting sites with them
- Ensuring patient documents are translated
- Managing trial supplies
- Arranging team meetings and taking minutes
- Facilitating coordination of ethics, regulatory and research and development (R&D) submissions
- Initial composition of Investigator Site File (ISF)
- Creating and maintaining study contact lists for study team and sites
- Setting up mail merges
- Archiving documents
- Sending study newsletters to sites
- Dealing with SUSAR notifications
CTAs should have five GCSEs grade A-C (including maths and English). Science A Levels could also prove helpful when trying to secure interviews, as could administrative qualifications.
For a CTA to gain promotion, a natural science degree such as biology or chemistry, or a health science degree such as pharmacy or nursing, is usually required.
- Project management skills
- Attention to detail
- Excellent organisational skills
- Methodical approach to work
- Computer literacy for updating spreadsheets, word process documents and search databases
- Ability to work in a team
- Good at meeting deadlines
- Ability to multi-task
- Proactive approach to work
- Good interpersonal skills
CTAs work normal office hours of 37-40 hours a week. Some may work overtime, and some may work at home, in which case they will be given a laptop. The office environment is not particularly hazardous, but companies usually give their employees training in any potential health and safety issues.
Becoming a clinical trials administrator assistant (CTAA) can be the first logical step to becoming a CTA. CTAAs support CTAs, performing tasks such as scanning, filing and laminating.
Ideally, potential candidates should have experience working in the pharmaceutical industry or in clinical research. However, recent graduates may be able to gain employment as a CTAA without prior experience.
For those applying without a degree, experience in other administrative roles, or at least temporary administrative roles, is important.
It may be possible to move straight into a CTA role without first being a CTAA.
Pharmaceutical companies frequently employ CTAs. The majority of them are based in the South of England. UK employers include Pfizer, GlaxoSmithKline, AstraZeneca and sanofi-aventis.
Biotechnology companies and contract research organisations (CROs) also employ CTAs.
A CTA could progress within their role and become a senior CTA. This would give them more responsibility as they would help to manage the CTA team on an operational level. Depending on the company, the next step could be a CTA manager position.
Senior CTAs can be termed ‘career CTAs’. These are highly experienced and knowledgeable clinical trial professionals who remain CTAs throughout their career. This is an option for the many CTAs who thoroughly enjoy their job.
Experience equals promotion, and there are many jobs into which an experienced CTA can move. They could become a clinical research associate (CRA), who in some companies are titled clinical research site managers (CRSMs). They set up the clinical trials and make site visits to monitor their progress. This job involves UK-wide travel so a driving licence is essential. Some graduates may begin their careers as CRAs, but this is unusual.
A CTA could also go on to work in a hospital, becoming a research nurse. Entry level (Grade E), research nurses coordinate the practical aspects of the clinical trial, and will play a part in the recruitment of trial patients.
The most senior grade (Grade I) leads R&D activity and puts the research teams together. See the Royal College of Nursing website for more information.
A CTA could also go on to work in a hospital as a clinical trials site co-ordinator, also known as a study site co-ordinator.
Also known as…
- Clinical Trials Assistant
What’s it really like?
Charlotte Parker tells us what it’s like to work as a CTA for a leading pharmaceutical company.
“I have been a CTA for over two years now. I left university with a biology degree and the desire to apply it to a job. To get some relevant admin experience, I did a stint at a local NHS hospital. I then applied to be a CTAA, got the job, and never looked back.
I was soon promoted to the position of CTA, and that is when I took on studies. I love my job; every day is different. I could be raising purchase orders, scanning documents into our electronic trial master file (electronic filing system for all clinical trial documents) or creating essential documents for the hospital staff working on the clinical trials.
I also regularly attend teleconferences and study-team meetings (I am now a well-practised minute-taker), co-ordinate ethics and research and development (R&D) submissions, and prepare for site initiation visits. This involves creating all the necessary site files and study specific materials. There are always things to be doing.
I currently work on five clinical trial protocols. The majority only have between four and six sites, but one has 40.
I work with a number of people. The organisational structure of our team is quite complex. For each clinical trial protocol I work on there is one global project manager and one country clinical project manager.
I also work closely with hospitals. Each clinical trial protocol is carried out in a hospital (we call them sites or centres), and each site is managed by a clinical research site manager (CRSM). I currently work with around 15 different CRSMs. Some manage multiple sites over the different trials.
I also work with the co-ordinator of the clinical trial at each site to ensure that the correct essential documents are signed, completed and returned. Sometimes I have to communicate directly with the investigators (doctors), research nurses and pharmacists. I also work with 12 fellow CTAs. We support each other in our workloads and take on some tasks as a group.
As you can tell, the ability to work in a team is essential to the role. You should also have good attention to detail, be able to use your initiative and be an extremely organised and efficient worker.
In terms of qualifications, you do not need a degree to do the job, though it of course helps when you are applying for jobs. Also, if you have an interest in science you can get a lot more out of the job. I am able to grasp the specifics of my clinical trials, and many of them are fascinating.
As for the future, I want to continue to learn about the clinical trial process. Perhaps I will go down the CRSM route, or maybe I will become a ‘career CTA’ and strive to be a fountain of knowledge on all aspects of the role. Even after two years, I still have a lot to learn.”