What Does a Clinical Trial Investigator Do?

Clinical trials may be conducted to discover the pharmacological effects of a product to determine the safety and effectiveness of that product for various diseases.
A clinical trial investigator oversees all aspects of a clinical trial, and may be assisted by sub-investigators.
In order to act as the principal clinical trial investigator, a physician is should have training and experience in the area in which the trial is being performed.
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  • Written By: Kevin P. Hanson
  • Edited By: C. Wilborn
  • Last Modified Date: 23 October 2014
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Clinical trials are an investigation using human subjects intended to uncover or ensure the clinical and pharmacological effects of a product to determine safety and efficacy. A clinical trial investigator is usually a physician in private practice who participates in these studies. This work may help to develop drugs and medical devices, determine effective treatments for various diseases, and provide patients alternative treatments.

A doctor does not need to have an association with a teaching hospital or medical school to be an investigator. He also does not need to have prior experience as a clinical trial investigator to qualify. The most important factor the physician needs to determine when considering if he is a good fit for the role is a thorough understanding of the commitment needed to conduct a clinical trial.

When a physician considers the possibility of participating in a clinical trial, he might want to consider if the trial will fit into his patient population. He should also consider if he or she has the equipment required to conduct the trial. Adequate staff to perform all of these duties is another requirement.

There are four main components of the clinical trial investigator team: the research subject, the principal investigator, the sub-investigator and the clinical research coordinator. The research subject is the person participating in the clinical trial. He or she may be healthy or infected with a disease or afflicted with a specific condition for the purposes of the trial.


In order to act as the principal clinical trial investigator, a physician is should have training and experience in the area in which the trial is being performed. The principal investigator oversees all aspects of the clinical trial. This includes, but is not limited to, the evaluation and treatment of research subjects, ensuring correct adverse event reporting, and designing a procedure for proper retention of documents.

Sub-investigators assist the primary clinical trial investigator. These roles are typically filled by either nurse practitioners and/or physician’s assistants. The clinical research coordinator runs all aspects of the day-to-day itinerary of the trial. Among the myriad duties performed by this pivotal role is the determination of the study’s protocol assessment and feasibility.


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Post 7

@Sunny27 - I agree with you and I wanted to add that the clinical trial monitoring process is critical because you want to make sure that any adverse effects of the medication in the study are recorded and dealt with before the medication is approved by the FDA.

I have seen a lot of clinical trials that have patient recruitment ads and I always wonder about the potential side effects of these studies and if anyone ever gets sick. I know that many times the participants are compensated for their time, but I wonder how many people participate in these clinical trials for the money.

I don’t know the clinical trial protocol, but how do they ensure that the participants are afflicted with the conditions of the study. For example, if this is a diabetes drug that they are testing do they give every participant a diabetes test to make sure that they have it? I always wondered about that.

Post 6

@SweetPeas - I think that clinical research investigators are doing a great service to society because their research can lead to the development of drugs that can enhance the quality of life for many people.

Sometimes it is through these clinical trial phases that people with a terminal illness get to try medication that might prolong their lives. I know that many people for example that have a stage four cancer diagnosis might feel more hope when they are exposed to these experimental drugs.

I hope that these clinical trial researchers do find a cure for this dreadful disease because we have lost too many people too soon. I know that the advances that they have been made thus far are a direct result of many of these clinical trials.

Post 5

@indemnifyme - It was probably really interesting for your friend to work as part of a clinical trial. I bet she probably couldn't tell you that much about what she was actually doing though. I know there are some pretty strict laws about patient confidentiality that I'm sure still do apply to clinical trials.

Post 4

A friend of mine got her undergraduate degree in biology and she worked in clinical trials for awhile. She told me that a good clinical trial investigator has to be meticulous and ethical, as well as dedicated.

Sometimes its extremely competitive to get funding for trials, and of course everyone wants to publish a successful paper. So it's extremely important the investigator be ethical enough to run the trial the way it should be run. Not to mention that they might be under a lot of pressure to succeed when testing a promising new drug.

I don't necessarily think working as a clinical trial investigator would really be a "break" for a doctor though. It sounds like a lot of work.

Post 3

I think that it's a good idea for physicians to take a break from seeing patients everyday and to work as a clinical trial investigator.

These important clinical trials need physicians who are well trained and experienced in the particular disease or medication that is being studied. This is a very different type of work than private practice and, I"m sure, that it brings a good feeling of satisfaction to the doctor. Being a part of an investigation that may bring benefit to a lot of suffering people would be very rewarding.

Post 2

I look for a variety of focus group jobs that companies or service organization use to get opinions and suggestions about the companies or service organizations. To become a part of a focus group, you must meet very specific criteria.

I often see advertisements asking for people to be part of clinical trials. To make the investigation non-biased, research subjects must meet particular criteria. This is where the clinical trial investigator comes in. He/she chooses and monitors the research subjects. The investigator is responsible for the reliability and accuracy of the trials.

Research subjects are given medication or various treatments for their ailment. Once in a while they may also receive a monetary award.

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