Clinical research seeks to find cures for cancer, diabetes, genetic diseases, and more. Clinical research professionals work as a team to innovate these medical breakthroughs.
A career in this field means learning how to protect the safety and well being of humans who participate in these trials while looking for the next generation of medical healthcare treatments.
What is a clinical trial?
A clinical trial comes about when a biotech, pharmaceutical, or device company wants to get regulatory approval for its product to market it. In order to get the approval of an agency like the FDA, it is required to conduct research in humans or a "clinical trial". The company that has the product is called the "Sponsor" of the clinical trial. The product that is going to be studied can be a drug, device, molecule, or a combination of them and is called the "Investigational Product" or IP. The Sponsor then comes up with a plan on how the clinical trial will be run. These instructions also include safety and background about the Investigational Product. The plan is called a "protocol" whose main purpose is to answer questions about how the IP works in humans who participate in the trial. The clinical trial can be in one country or can be worldwide in multiple countries.
Who manages a clinical trial?
The Sponsor overall is responsible for the trial conduct; however, the Sponsor outsource work to another company called a "Contract Research Organization" or CRO. The Sponsor and CRO work together in overseeing the study. There may be one or multiple CROs involved in a clinical trial.
The Sponsor or CRO will find different doctors called "Investigators" in many different locations who agree to follow the protocol and will administer the Investigational Product at their clinic. The Investigator is assisted by a "Study Coordinator" (SC) or "Clinical Research Coordinator" (CRC) at the medical clinic who helps the doctor to manage the study. A CRC can be a nurse, medical assistant, or other clinic staff. A position that links the Investigator's sites to the Sponsor/ CRO is called a "Clinical Research Associate" or CRA. The CRA works on behalf of the Sponsor or CRO to oversee the site. This means reviewing all the study documents (medical records, trial data, study correspondence) to ensure that the clinical trial is being conducted according to the protocol and regulatory requirements. If CRA provides training and feedback to the site staff to ensure to help them keep compliant. Overall the Investigator is responsible for all work done at the site but the CRA works in collaboration with the site to make sure quality research is being performed. The CRA travels to the different clinics to perform on site review and mainly works with the CRC during these "monitoring visits".