As a Clinical Research Associate (CRA) your role is to manage research and ensure the obtained data is organized. It is a profession that is more along the lines of a career in the documentation of information but with an edge over the standard job expectations.
You work in be to coordinate the collection, sorting, distribution, and storage of information obtained during clinical research trials. It may look somewhat straightforward, but it is a job with a few responsibilities that include:
- Developing and document clinical trial protocols
- Developing data collection templates and forms
- Ensuring the trials are done in coordination with, and adhering to the standards set by the Ethics Committee
- Setting up trial sites and that the tests are done in line with set protocols and regulations.
- Educating doctors and other medical personnel as well as the patients about the trials
- Monitoring the activities of the trials across every site and reviewing the data in preparation for submissions.
- Preparing presentations, reports, and publication papers
From the above, it is clear the work of a CRA is not limited to any particular department or research site. The research associate has to work and coordinate with different people across the various setups within the organization.
Those who study and qualify to be CRAs can find work in CROs (Clinical Research Organizations) or even biotech companies, pharmaceuticals, or hospitals. Here are five reasons from ICON you should consider this career.
To attain the certifications for the job, you need to have a graduate or post-graduate degree in medical sciences, nursing, or life sciences. Also, you should be familiar with any of the following subjects – microbiology, biochemistry, physiology, biology, toxicology, anatomy, chemistry, immunology, or pharmacology. When looking for employment, having a post-graduate degree in clinical research means you have added knowledge of clinical testing and trials and this give you a competitive edge.
It is virtually impossible to works as a CRA without having a graduate degree. It is possible to find work when working in other professions while handling CRA related administrative duties. However, pursuing certain courses in medical and clinical research and help further your credits in the profession.
Clinical trials are done in phases and take place in different places with the CRA involved in every stage of the tests. The CRA should have management skills that are more or less similar to what is required when managing projects. And besides the project management skills, the research associate should have the following skills.
1) Excellent communication skills:
The job requires talking and education different people about the trials. As such, the CRA should have excellent writing and oral communication skills.
2) Attention to detail:
The volume of data in any clinical data is a lot, and most drugs are approved or rejected by the respective regulatory authorities based on the trial data. Therefore, the CRA should have staunch attention to detail and excellent data analysis skills.
3) Organizational and time management skills:
The clinical tests are done based on set plans that have established protocols and timelines, which means the research associate should have outstanding organizational and time management skills.
4) Excellent IT and administrative skills:
The research will involve handling and reviewing different data, much of which will be in computerized form and processes which demand good IT knowledge and sturdy administrative skills.
Handling trials that are running simultaneously in various locations and times demand the CRA to be able to know how to multi-task and think on his or her feet.
Career Prospects And Salary
CRAs work at different levels in an organization, with departmental duties allocated based on their abilities and level of experience. A research associate working for the first-time in the profession will often start off as a research administrator and then graduate to a research associate while on the job and learn the ropes.
The professional levels of CRAs are CRA level I to Level III and then Senior CRA, that is the order of ranking. The duties and responsibilities of the CRA differ from one to the other based on their level of employment. Those in level I help in setting up the clinical trials and collecting and collating data. The Senior CRAs are part of the team that designs the trial protocols and have a more involved role in the management of the clinical tests across all the sites and is part of the training and mentoring of the junior staff.
The salaries are determined by the skill and experience levels of the CRA. The salary for a CRA entry level position is around $30,000 to $38,000 with it shooting upwards to approximately $90,000 for the Senior CRA position. But, the salaries will vary from organization to organization.
The work duties vary with the CRA doing a lot of traveling between the clinical trial sites. Works hours are 9 to 5 but with some extra hours occasionally called for especially if clinical tests are running. Car allowances and additional payments are some of the perks companies offer their CRAs to compensate for such circumstances.
The CRA profession does have opportunities for contracted work and part-time jobs. You can opt to work as a freelance consultant if you the necessary qualifications and experience in clinical research. Most of the freelance CRAs started their careers working with CROs, climbed the ranks to Senior CRAs and then retired or resigned to work as freelancers.
Staying current with the latest regulations for the profession is essential for your professional development as successful career as a clinical research associate. You should consider taking a certificate or diploma course at the Institute of Clinical Research to bolster your skill and knowledge as well as bolster your credits for your professional advancement.