A Clinical Research Associate is a healthcare professional who play vital roles in activities related to medical research (clinical trials). CRA job is all encompassing and it spans through participating in clinical trials, testing new or existing drugs for efficacy, safety and benefits, working in collaboration with clinicians performing clinical trials to ensure accuracy of data and results obtained. This is to make sure that these drugs are safe prior to their release into the market.
Choosing Clinical Research Associate job as a career, one could work either for a pharmaceutical company or for a Contract Research Organization; CRO (third party research companies, that is, companies that carry out research on behalf of other companies).
Clinical trials are usually done in stages and/or phases. A CRA is always involved in all stages of clinical trials (from identification of the investigational site, setting up the processes, initiation stage, monitoring to when results are obtained).
The roles of a CRA, depending on the employer and the company policy, typically include:
- Developing and writing the purpose/ the protocols of a trial,
- To tender the trial protocols to the committee,
- Developing the Case Report Forms; CRF (for data collection),
- Working collaboratively with the ethics committee to ensure the safety and wellbeing of the subjects used for trials,
- Oversee the management of regulatory applications and approvals that control the research/marketing of drugs (new and existing drugs),
- Investigating the suitability of facilities to be used as the site for the trial,
- Effective interpersonal communication with other healthcare professionals during the trial(s),
- Proper management of the trial sites; providing trial materials at sites and ensuring that staffs are trained to meet up with the industrial standard requirements for trials,
- Monitoring trial processes throughout the trial period,
- Verifying the consistency of data obtained,
- Gathering the completed Case Report Forms(CRF),
- Filling and computing trial documentation and writing visit reports,
- Documenting how the trial supplies are used,
- Closing trial sites on completion of trial(s),
- Discussing the results obtained with the medical personnel who usually collates the trial reports,
- Ensuring that data obtained in the study are properly documented,
- Preparing the final trial reports and sometimes the manuscripts for publication.
Clinical Research Associate Salary
The Clinical Research Associate Salary would vary due to factors like the individual’s level of education, experience, the CRA certification, place worked, project funding levels and others.
In the United States, there are no particular salary data meant for a Clinical Research Associate and/or a Clinical Research Assistant.
With reference to the United States Bureau of Labour Statistics, the (median) annual salary for people in the Medical and Clinical Laboratory Technologists and Technicians work group amounts to 46,680 USD. This will give an idea of the salary of a CRA. Additionally, a Clinical Laboratory manager in the United States earns 62,910 USD per annum.
In line with the CRA role performed, the Association of Clinical Research Professionals (ACRP), by offering the designation of CCRA (Certified Clinical Research Associate), provides certification for all CRAs. That is, to become accredited as a CCRA, the CRA have to pass a CCRA tests with some additional requirements.
Usually, the Association of Clinical Research Professionals’ CRA certification program is usually accredited by the National Commission for Certifying Agencies.
On the other hand, the society Of Clinical Research Association (a non-profit organization) also provides CRA Certification and as well provides training, continuing education program geared towards the development of clinical research.
The CRA career structure would vary from one organization/company to another. However, one who has chosen this profession as a career could advance depending on skills acquired, level of motivation as well as the proficiency in the use of skills acquired.