To Be a CTA (2005)

This is a career guide about becoming a Clinical Trial Administrator.
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9 G% f, |! N3 }  g6 X' JA clinical trials administrator (CTA) primarily manages the administrative aspects of a number of clinical trials, at every stage of the process.
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- Y, S2 B' k9 z5 Z/ BClinical 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.

9 F. ^8 h5 P) E1 j2 }0 Z" m& x1 \% yCTAs 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.
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- P: W  I# b6 c' w, ^+ _The role of any clinical trials professional is extremely important, because medical treatment can save – and dramatically improve the quality of – people's lives.
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CTAs 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.
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# d8 c  `" v. S1 O$ o. XCTAs are office based, and spend the majority of the day working on a computer. 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.
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CTAs frequently use Microsoft Excel, Word, PowerPoint and database management systems. Pharmaceutical companies may also use their own software. Computer literacy is therefore essential.

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.
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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.
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As with many administrative jobs, there tend to be more female than male CTAs.
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; r4 M. P" G1 r0 o5 k- ?1 PSalary
In general the pharmaceutical industry pays well. CTA salaries range from £18,000 to £30,000 per year, depending on experience. Graduates can often demand higher salaries.


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& c. _( H* C3 f+ |5 B) D7 q' kResponsibilities
Preparing essential clinical trial documents
Tracking, distributing and filing documents when they are returned
Re-ordering drugs on behalf of sites
/ ~9 a  r% X6 gMaintaining 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
4 A! R, j! A0 L0 h+ N, `Raising purchase orders to pay investigator sites
4 H  G. B3 [* _: B' F  j; ySupporting clinical research associates (CRAs) and perhaps visiting sites with them
Ensuring patient documents are translated
; |! d7 \" p. _( ]Managing trial supplies
Arranging team meetings and taking minutes
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2 @. @5 @5 n; }  h$ d& RFacilitating coordination of ethics, regulatory and research and development (R&D) submissions

$ q- ?! k5 j, sInitial composition of Investigator Site File (ISF)

Creating and maintaining study contact lists for study team and sites

Setting up mail merges
8 e* g9 H, H5 x6 Z4 N4 f: c% ^Archiving documents
Sending study newsletters to sites
Dealing with SUSAR notifications
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, C$ O" \" f; ?4 y: r4 aQualifications
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.
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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.
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% ?# A+ {& J2 q- z$ O& lSkills
Project management skills
Attention to detail
* ]  F- S2 `* ^: x" E% o7 ]Excellent organisational skills
Methodical approach to work
% G+ R. X3 [) z# c& h' L3 M9 dComputer literacy for updating spreadsheets, word process documents and search databases
# h# i$ S* v! @# l/ x/ b7 sAbility to work in a team
Good at meeting deadlines
Ability to multi-task
$ ~0 z6 Y/ t- k" F- u& k1 VProactive approach to work
7 F5 a1 d' Q; w% c# r+ PGood interpersonal skills
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Working Conditions
2 t7 [3 N, _( o) xCTAs 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.
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Experience
# ^* g0 P) I. @3 X* L' dBecoming 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.
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+ Z3 E- m  y6 d# Y0 O9 s& QIdeally, 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.

% `" \: l' V; ~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.
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' n' f/ U4 b3 o/ e% }7 oEmployers
, b$ I5 \: Q/ D/ J% \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.
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1 z" B5 p: A& ?9 r+ P* J: X, wCareer Progression
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.
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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.
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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.
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. m" r9 K+ M) b2 [7 @5 UThe 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.
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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.

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