Clinical research job description: what does a clinical researcher do?

Do you know what a clinical researcher is and what his job consists of? In this article we’ll go through all the details surrounding this exciting profession.

What is a clinical investigator? The different professionals in clinical trials

As you already know, clinical trials involve research procedures that take place in the last stages of the development of new medicine products with the aim of verifying their efficacy, safety and potential adverse effects.

Thus, after a long phase of preliminary research, the clinical trial process is the decisive step before a new drug can be finally launched and marketed.

Well, throughout this phase, a series of professionals participate and assume different roles and tasks in trial developments. Since these descriptions can sometimes be a bit confusing, it is best to look at those used by official regulators.

Different countries present different regulations regarding clinical trials with drugs, which tend to target a multitude of aspects, including ethical issues. Additionally, regulations typically define the different professional profiles involved in clinical research, which can include:

• Sponsor: the individual, company, institution or organization responsible for initiating, managing and organizing the financing of a clinical trial
• Researcher: the person in charge of conducting the clinical trial at a clinical trial center
• Principal investigator: the lead researcher for a team, in charge of conducting clinical trials at a clinical trial site
• Coordinating investigator: the researcher responsible for coordinating the investigators of the participating centers in a multicenter trial
• Hired clinical researcher: a researcher hired by the center or research institutions related to it to carry out one or more clinical trials, provided they have the required qualifications to carry out the functions assigned to them and can carry them out following the center’s safety guidelines
• Clinical research monitor: trained professional with the necessary experience and clinical and/or scientific capabilities, chosen by the promoter to be in charge of direct monitoring of the trial. He or she functions as a link between the promoter and the principal investigator, when they are not the same person. The monitor should never be part of the research team. 

Let’s now see more details of the main tasks that correspond to some of these professionals and the official clinical research job description applied to them.

The role of the monitor in clinical research

The so-called ‘monitor’, which is also known as Clinical Research Associate (CRA), is one of the most important links in the clinical research process. As we said, this position is only suitable for a professional with clinical and/or scientific training, usually in the health area.

Among other responsibilities, the clinical research monitor is responsible for the following tasks:

• Work in accordance with the sponsor’s standard operating procedures, visit the investigator to verify compliance with the protocol, ensure that data is recorded correctly and thoroughly, as well as ensuring that informed consent has been obtained from all subjects before they are included in the trial.
• Make sure that the researchers and the center where the research will be carried out are suitable for this purpose.
• Ensure that both the principal investigator and her collaborators have been adequately informed and can guarantee rapid communication between the investigator and the sponsor at all times, especially in terms of trial safety supervision.
• Send reports of monitoring visits and contacts made between researcher and promoter.

What does a clinical investigator do? The tasks according to a clinical research job description

As is often stated by norms regulating the clinical research job description, the researcher directs and is responsible for the practical implementation of the clinical trial.

In order to assume this responsibility, regulations often demand this position to only be fulfilled by a doctor or a person who has been officially recognized to carry out clinical research due to his scientific training and his experience in a related healthcare area.

In this context, the main functions of the clinical investigator include:

• Signing the trial protocol together with the sponsor
• Having in-depth knowledge of the properties of the drugs being investigated 
• Guaranteeing that informed consent is collected in accordance with the provisions of official regulations.
• Collecting, recording and notifying data correctly and guaranteeing its veracity
• Following instructions regarding the communication protocols in case of adverse occurrences
• Immediately notifying the promoter in case of serious breaches of the protocol
• Ensuring that all people involved in the clinical research respect confidentiality around any information about the subjects, as well as the protection of personal data
• Regularly informing the corresponding ethics committee about the trial progresses 
• Being co-responsible (along with the promoter) for the preparation of the trial’s final report and giving their agreement using their signature.

What do I need to work as a clinical investigator or collaborate with one?

As you have seen, a large number of professionals take part in the research and clinical trial process. For some of them, regulations can provide some sort of indication regarding the required degrees or qualifications.

For example, this is the case of the clinical research job description (in a strict sense). As we’ve described in the previous section, this person must be a doctor or a person who has been officially recognized to carry out clinical research due to his scientific training and his experience in a related healthcare area.

In any case, logically, within the framework of research and clinical trials, a large team of professionals will be needed to collaborate as well as distributing the different tasks in a coordinated manner.

For example, in order to participate in clinical analysis within a trial process, specialized professionals in this specific area must be available. Proof of this can be provided through a master’s degree in clinical analysis or other similar training. The same will happen for the other required tasks involved in the research and testing process.

In short, the standard clinical research job description involves tasks essential to guarantee the efficacy and safety of a new medicine before it reaches the market. Similarly, a carefully designed and supervised protocol is required, in addition to the collaboration of a large team of professionals who deal with the different tasks involved in a trial process.

If you are interested in this profession, make sure you get specialized training as soon as possible, so that you can start your career in a field that is both demanded and exciting.