A clinical research associate (CRA) is a health professional responsible for medical research-related activities such as clinical trials. This research is mostly carried out in institutions like pharmaceutical companies and medical research institutes.
CRAs are in charge of training and supervising the administrative staff and overseeing the research. However, their main role mainly involves assessing the interaction of the drugs with the subject patients, their benefits, and any risks that arise from using them.
A clinical research associate should be able to multitask since they may be assigned other miscellaneous duties depending on the trial. Here are nine of the most important roles that clinical research associates play in their field.
9 Roles of a Clinical Research Associate
Some of the roles of the CRA include but are not limited to:
Identifying, Setting Up, and Disbanding of Study Sites
It is the responsibility of the clinical research associate to find a suitable site to carry out the research and investigations. After finding a fitting study center, the CRA is expected to see that the area is well set up and that all materials needed for the study are available. The CRA is also required to regularly visit the site and ensure that everything is running smoothly before the study begins.
At the end of a study trial, the clinical research associate dissolves the study and sends a close-out report to the sponsor and site investigator to close the study site.
Coordinating and Overseeing Research and Trials
The CRA oversees the clinical study and monitors the progress of the clinical trial. One of the major roles of the CRA is to ensure that the data provided from the trial is complete and accurate. In addition, they see to it that every site follows protocol and compliance.
It is also their responsibility to ensure that every material needed for the study is available until the end of the study. Moreover, CRAs foresee hiring qualified staff to participate in the research. In addition, they keep in touch with the sponsors and inform them of the progress and any changes made in the study.
Managing and Supervising the Administrative Staff
Clinical Research Associates participate in the hiring of the right individuals to carry out the research. They then ensure that the selected staff are well trained and understand the standard operating procedures. This entails delegating and distributing the workload.
Since the CRA acts as a manager, they have the right to recruit and fire staff. In addition, the CRA conducts meetings and briefs the staff on any new changes. It is also their responsibility to offer support to the trial investigators. They listen to any challenges the staff may be facing and provide solutions where possible.
Lastly, they ensure that employees receive their salaries and incentives. It is the responsibility of a CRA to maintain a good working environment at the study site.
Collecting, Evaluating, and Verifying Data
CRAs manage data in the study area. They collect data and ensure that the data presented is accurate and verifiable from source documents. The CRA keeps a record of data provided to help them create reports. One of the most important skills a CRA should have is an excellent numeracy grasp to help them verify data. The CRA fills case report forms, but sometimes they may be required to enter data electronically.
A clinical research associate often conducts site visits to keep track of the data and prepare evaluative reports. They act as the eyes and ears of the sponsors and report on what is happening at the site. Moreover, they give a detailed report on whether there are enough employees and indicate present and missing materials on the report. They further report on the methods used in the trial and the findings. In case of discrepancies, the CRA informs the research manager or sponsor.
Recruiting Participants for the Trial
CRAs help in the recruiting of participants to be used in the trial. They collect participants’ data while ensuring that the safety and rights of the patients involved in the study are protected. The CRA must obtain consent from all the participants before any study is performed and ensure that the subjects’ information remains confidential.
Conducting Study on Products and Procedures to Be Used in Research
It is the obligation of the CRA to conduct a study on the drugs, pharmaceutical products, or vaccines used in the study. The CRA should ensure that these products are not harmful in any way. In addition, they should guarantee that the procedures used are safe and that the products can be released to the market. The CRA should also see that all the standard procedures were followed during the study.
Conducting Regular Site Visits
Clinical research associates are advised to visit the study sites regularly. The presence of the CRA at the study site helps maintain good progress, keeps the staff informed and motivated, and keeps accurate reports. They can also conduct virtual visits when it’s impossible to go to the site.
The CRA can determine if the protocol is being adhered to by being present at the site. CRAs interact with medics in hospitals and health centers used as sites to conduct the study. During the field visits, they may hire backup staff if some researchers quit.
Maintaining and Managing Clinical Data
The research data should be as per the standard of the local regulations. The clinical research associate should ensure that the data provided is complete, verified, free from errors, and up to date. This role also entails providing data that is ready for analysis at the end of the trial.
A CRA has endless duties and responsibilities. Therefore, they possess important skills like multitasking, a keen eye for detail, and numeracy. Additionally, CRAs have great people skills as their work entails interacting with various researchers, patients, medics, and sponsors. Therefore, they should be able to relate well with staff and colleagues for the clinical trial to become successful.