Often fulfilling a temporary role for the purpose of a study, a clinical trial investigator may give medication to voluntary human subjects to discover how they react to the drug's influence, or see how individuals react to a specific medical device. Since these investigators are often professional physicians or psychiatrists, a doctorate degree in medicine is usually required. In the cases where the investigator is not a doctor, however, a strong scientific background is usually mandatory in order to properly conduct a trial.
Clinical trial investigators test the effects of medication and medical devices on humans. They may identify participants for the clinical trial, administer medication, utilize medical devices and submit the information they gather to their employer. Their work may be regulated by the U.S. Food and Drug Administration. Employers may prefer investigators who also work as physicians or psychiatrist due to their medical knowledge.
|Required Education||Professional doctorate, typically in medicine|
|Other Requirements||Physician licensure, on-the-job training|
|Projected Job Growth (2018-2028)||8% (medical scientists)*|
|Median Salary (2019)||$98,320 annually (clinical trial manager)**|
Source: *U.S. Bureau of Labor Statistics, **Payscale.com
Job Description of a Clinical Trial Investigator
A clinical trial investigator administers medication or use medical devices on a group of patients to determine its influence. Some of these professionals are physicians due to the medical knowledge and expertise needed to prescribe the medication or use the device.
Usually, these individuals are not full-time investigators and act as an investigator in addition to their main job. For example, a private practice physician may sign up with a pharmaceutical company to work as an investigator for a specific medication. After doing so, the physician is a clinical trial investigator, but is also still a physician working in private practice.
An investigator usually receives training on the procedures and components of a trial, which may be conducted by a pharmaceutical company, government agency, or hospital. Some investigators, such as those who work in academia, may initiate trials on their own.
In this case, they are not trained in trial procedures because they establish the procedures themselves, but still may need to comply with government rules. An investigator may work in conjunction with physicians, nurses, or other healthcare workers.
The job duties of a clinical investigator differ depending on the trial's parameters. Generally, they identify a group of patients or individuals that are eligible and suitable for the study, including a group that can be used as the control group who are given the drug or other main component of the trial so that their reaction can be used as a comparison.
Investigators may administer the medication or use the machine on group members over a period of time. They will meet with group members several times, if necessary, and record their responses or other pertinent information.
They generally submit the information they gather to the company or interpret it themselves and write a report. The trial's results may be used to obtain approval for medication, determine proper administration techniques, identify possible side effects, craft warnings, or any other related purposes.
The requirements to become a clinical trial investigator are determined by the company or agency running the trial. Prospective investigators may need to be a physician or psychiatrist, have prior experience conducting trials, regularly see patients requiring the type of care the medical device treats, or have the scientific knowledge necessary to conduct the trial.
All investigators must abide by a set of rules, which differ depending on the type of trial and field of science the trial involves. Sometimes, investigators must be registered with a federal agency. There is no required certification or licensure required to work as a clinical trial investigator; however, voluntary professional certification is available.
Salary Info and Job Outlook
According to PayScale.com, most clinical trial managers earn a yearly salary of $65,000-$132,000, as of September 2019. The U.S. Bureau of Labor Statistics (BLS) indicated that the employment of all types of medical scientists is projected to increase much faster than average between 2018 and 2028.
Following a study's specific guidelines and outlined procedures, clinical trial investigators work in a variety of industries that might include academics, government, healthcare, or pharmaceutics. It is up to the investigator to gather and report data from a trial for further research.