How To Get Certified As A Clinical Research Associate

Clinical research associates are certified professionals who work alongside researchers in clinical trial studies. Their job is to ensure that protocols are followed as defined, and that any scheduled methods are done in the way the study demands. They are responsible for making sure that human test subjects are treated properly, that data is recorded accurately, and that information is communicated to the researchers in a timely and accurate manner.

 

Clinical research associates may also be involved in recruiting human test subjects, case management of subjects, development of informed consents, grant and budget development, and education of health-care professionals, subjects, and families regarding the nature of the clinical trial. They also travel from one test site to another to monitor patients.

 

Certification is important because it gives you credibility and is believed to reduce risk to the test subjects. It also proves to the FDA that your team of researchers is well-qualified to conduct clinical trials.

 

 

Most clinical research associates have a degree in life sciences with additional training and certification required. They can expect to make salaries in the high $50s and low $60s. They can be certified through the Society of Clinical Research Associates or the Association of Clinical Research Professionals.  Training is available online, in the classroom, or some combination of both. Following their training, candidates must take a comprehensive certification exam. These exams are offered at various times and at various sites around the country.

 

Candidates for certification include MDs, RNs, and those with undergraduate or graduate degrees in science, health science, pharmacy or a related field.  It is expected that they will also have a minimum of one year of full-time employment in the field. Some programs require at least two years of full-time experience or equivalent part-time clinical experience.

 

 

The examination for certification covers the proper conduct of clinical trials, institutional review boards and regulations, ethical ramifications, the ability to follow directions carefully and precisely, and abstracting information from medical records.

 

Conduct of clinical trials covers things such as research protocol development, study design, grants and funding, records retention, adverse events, monitoring and quality assurance, informed consent, and other aspects of the actual trial.

 

Institution review boards are the overarching agency that governs clinical trials at the institutional level. This portion of the exam includes reporting requirements, clinical drug requests, FDA compliance, and accountability.

 

The ethical portion of the certification exam covers informed consent, clinical fraud, and the disclosure of clinical information.

 

To ascertain the candidate's ability to follow directions, they will be tested on schedules and dose modification, as well as the ability to follow directions.

The final portion of the exam includes mathematical calculation, reading clinical reports, and reading medical records.

 

 

Once certified, clinical research associates are expected to keep their skills up to date through ongoing professional education, participation in conferences, and recertification exams. Recertification is required every three years and candidates must have completed 45 hours of continuing education pertinent to the area of clinical research they have been employed in during the three years prior to recertification.