A clinical research associate (CRA) sets up, monitors and completes clinical trials.
A clinical trial is a scientific study of the effects, risks, efficacy and benefits of a medicinal product. Trials need to be carried out before a product reaches a hospital or the shelves of the local pharmacy. They are undertaken 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 product to monitor safety and side-effects during large-scale use.
Clinical trials are conducted by pharmaceutical companies or contract research organisations (CROs) on their behalf.
» Typical work activities
Typical work activities include:
•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 record forms (CRFs);
•co-ordinating 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);
•locating and assessing the suitability of facilities at a study centre;
•briefing doctors/consultants (or investigators) on conducting the trial;
•setting up the study centres, which includes ensuring each centre has the trial materials and training site staff to trial specific and industry standards;
•monitoring the trial throughout its duration, which will involve visiting the study centres on a regular basis;
•verifying that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV);
•collecting completed CRFs from hospitals and general practices;
•writing visit reports;
•filing and collating trial documentation and reports;
•ensuring all unused trial supplies are accounted for;
•closing down study centres 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.
The job of a clinical research associate (CRA) can vary tremendously. In some companies, you would be involved in the whole process: sitting down with the doctor who has the idea for a trial; working out a protocol; and writing up reports after the analysis has been done. In others, a medical adviser would initiate the trial - the CRA would become involved in collecting data once the trial had been set up.