Clinical trials need to be carried out by a professional and experienced team of researchers. One of the main roles belongs to the clinical research associate (CRA) is to help test new treatments such as drugs for their safety, effectiveness and health benefits. More often than not, a clinical research associate is employed by a pharmaceutical company via organisations such as G and L Scientific, to get involved with various stages of the clinical trial. When searching for ideal clinical research associates, it can be difficult to know what to look for, which is why we have included the most important qualities and skills every CRA should have.
Trained in ICH/GCP Guidelines
Proper training is required in both ICH and GCP guidelines. In top of this, additional training is necessary in the Code of Federal Regulations, EU Clinical Trial Directive and sufficient knowledge in the associated local regulations.
Excellent Development and Protocol Writing Experience
A professional CRA is required to both develop and write trial protocols. The clinical trial protocol is important because it describes the purpose and methodology of the trial at hand. In order to correctly steer committees, the CRA must also be able to present trial protocols and design case report forms concerning the clinical trial.
Directing with Ethics Committees
It lies in the hands of the CRA to coordinate with the ethics committee. This is necessary to ensure the safety and wellbeing of the volunteers who are participating in the trial.
Managing Regulatory Authority Applications
The right CRA will be more than able to manage regulatory authority applications and approvals. According to Prospects, these documents are used to oversee the “research and marketing of new and existing drugs”.
Identifying and Assessing
There is a great deal of close assessment required in this line of work, including the identification of suitable trial sites, the selection of a responsible investigator and reviewing competitive landscapes.
Setting up Trial Sites
The process of setting up trial sites involves ensuring that the right trial equipment is available in each of the centres involved. The investigational medicinal product should also be available. In addition to this, each member of staff on site should be trained to meet the trial-specific standards in the industry.