What is CRA?

Clinical Research Associate (CRA):

Job Description and Activities

Job Description

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. These need to be carried out before a product reaches a hospital or the shelves of the local pharmacy. Trials 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 Organizations (CROs) on their behalf.

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 report forms (CRFs);
Co-coordinating the ethics committee, who safeguard the rights, safety and well-being of all trial subjects;
Managing regulatory authority applications and approvals, who oversee the research and marketing of new and existing drugs;
Locating and assessing the suitability of facilities at a study center;
Briefing doctors/consultants (or investigators) on conducting the trial;
Setting up the study centers, which includes ensuring each center has the trial materials and checking that the investigator knows exactly what has to be done;
Monitoring the trial throughout its duration, which will involve visiting the study centers 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 centers 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.