A clinical research associate (CRA) runs clinical trials to test drugs for their effectiveness, risks and benefits to ensure they are safe to allow on to the market. They may work on new as well as existing drugs and are usually employed by either a pharmaceutical company or a contract research organisation which works on behalf of pharmaceutical companies. The clinical research associate will typically be involved in all stages of the clinical trial, including identifying an investigational site and setting up, initiating, monitoring and closing down the trial. Clinical trials may be carried out at various stages or phases and include trials on healthy humans, trials on patients with a disease, and studies conducted after the launch of a new drug to monitor safety and side effects.
Typical work activities
- Developing and writing trial protocols (outlining the purpose and methodology of a trial).
- Presenting trial protocols to a steering committee.
- Designing data collection forms, known as case report forms.
- Coordinating with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects.
- Managing regulatory authority applications and approvals that oversee the research and marketing of new and existing drugs.
- Identifying and assessing the suitability of facilities to be used as the clinical trial site.
- Identifying/selecting an investigator who will be responsible for the conduct of the trial at the trial site.
- Liaising with doctors/consultants or investigators on conducting the trial.
- Setting up the trial sites, which includes ensuring each centre has the trial materials, including the trial drug often known as the investigational medicinal product. Plus training the site staff to trial-specific industry standards.
- Monitoring the trial throughout its duration, which involves visiting the trial sites on a regular basis.
- Verifying that data entered on to the case report forms is consistent with patient clinical notes, known as source data/document verification.
- Collecting completed case report forms from hospitals and general practices.
- Writing visit reports and filing and collating trial documentation and reports.
- Ensuring all unused trial supplies are accounted for; closing down trial sites on completion of the trial.
- Discussing results with a medical statistician, who usually writes technical trial reports.
- Archiving study documentation and correspondence.
- Preparing final reports and occasionally manuscripts for publication.
- Excellent communication skills (both written and oral) and the ability to build effective relationships with trial centre staff and colleagues.
- Ability to motivate others.
- Numeracy and an eye for detail.
- Ability to multi-task and think on your feet.
- Good organisational, IT and administrative skills – the job involves a lot of documentation and recording of information through computerised processes such as clinical trial management systems and electronic data capture.
- Good clinical practice.
Career structures vary from company to company. How quickly you can move up the grades depends on a range of factors including motivation, ability and previous experience. Before becoming a clinical research associate, you may begin at a lower level such as a clinical trial administrator or junior clinical research associate. Once you have progressed to the clinical research associate role there are several different levels you can work at which include:
CRA level I – working on pre-trial procedures, setting up and organising clinical trial sites (with
some supervision), archiving documents and correspondence.
CRA level II – selecting investigators, coordinating ethics committee and regulatory authority applications, supervising trial supplies and attending investigator meetings.
CRA level III – any of the above tasks plus supervising, training and mentoring junior staff, project management of whole trials possibly on an international scale, protocol development and design of case report forms.
If you work within a contract research organisation you can build up and widen your experience with a variety of sponsor pharmaceutical companies in different therapeutic areas and in different phases of clinical research. This could allow you to move to a pharmaceutical company.
Self-employment may be possible, as CRAs are often employed on a freelance basis by certain companies but should only be considered when you have developed experience, contacts and clients.
Original content at prospects.ac.uk