03-25-2006, 10:31 AM
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 organisations (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 record forms (CRFs);
co-ordinating the ethics committee, who safeguard the rights, safety and wellbeing 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 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 checking that the investigator knows exactly what has to be done;
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.
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; writing up reports after the analysis has been done. In others it would be a medical adviser who initiates the trial - you would just be involved in collecting data once the trial had been set up.
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 organisations (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 record forms (CRFs);
co-ordinating the ethics committee, who safeguard the rights, safety and wellbeing 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 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 checking that the investigator knows exactly what has to be done;
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.
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; writing up reports after the analysis has been done. In others it would be a medical adviser who initiates the trial - you would just be involved in collecting data once the trial had been set up.