A clinical investigator is responsible for conducting clinical medical research studies while following the specified procedures for the collection of data and ensuring that the subjects' rights and welfare are protected. This person may also be called a clinical trial investigator or clinical research investigator. The investigator is usually a trained medical researcher or a doctor; clinical studies may take place in a variety of settings. Investigators typically collect data about the usefulness of specific pharmaceutical drugs or medical devices in clinical settings. The clinical investigator conducts and oversees research studies, often working with a team of researchers.
The clinical investigator must follow instructions from the entity requesting the study, such as a drug company, medical device manufacturer, or the U.S. Food and Drug Administration (FDA). These instructions are usually contained in a document called the investigator statement. These instructions generally detail the way that the investigator is supposed to gather and analyze study data. The instructions also usually specify the number and type of study participants and the manner in which the drug or device being studied will be used by them. It is the clinical investigator's job to make sure these instructions are followed as faithfully as possible.
Generally a clinical investigator is a highly trained medical researcher or a doctor with additional training in research methodology. He or she may work in a variety of settings such as conducting studies in a large lab, at a drug company, or in a small private medical practice. Once chosen to perform a study, the investigator is often responsible for providing research space. This includes a location for meeting with and examining participants, storage for the drugs or devices being studied, lab space, and record keeping. The investigator is responsible for maintaining these facilities to the required standards.
Another responsibility of the clinical investigator is selecting participants, or subjects, who meet specified criteria for the research study. Through regularly scheduled visits and examinations, the investigator monitors progress, collects data, and makes sure that the participants follow protocols. He or she is also responsible for ensuring the safety and welfare of study participants, and protecting their rights. This includes providing medical care related to the study and protecting the subjects from unnecessary risk or privacy violations. The investigator is also responsible for excluding flawed data from the study if subjects do not follow required protocols, to protect the accuracy of the results.
In large research studies, the clinical investigator may work with a team of researchers. In such cases, the investigator is responsible for delegating appropriate tasks to study staff and supervising them. He or she must oversee all aspects of the study to ensure that it is being carried out in the required manner and will yield accurate, useful results.