Clinical Research Associate (CRA): The Monitor of a Clinical Trial
The clinical research associate who is also called the trial monitor or the clinical monitor may work independently or with a contract research organization helping to monitor if the clinical trial activities are being conducted according to the FDA framework as well as sponsor requirements. The clinical research associates could work in various settings such as with pharmaceutical companies, medical research institutes and government agencies. The main tasks of the CRA are defined by good clinical practice guidelines for monitoring clinical trials and has been elaborated by the International Council for Technical Requirements for Pharmaceuticals for Human Use. The role played by a CRA would help to grow into a feasibility leader, start-up specialist as well as a project manager. The CRAs are usually required to have an academic qualification in Life Sciences and a thorough knowledge in local regulations and good clinical practice.
Typically, the main responsibilities of a CRA involves monitoring study sites and clinical activities, updating study documentation as well as maintaining the clinical data systems and coordinating research procedures. The role of the CRA also includes:
Helping in developing and writing of clinical trial protocols
Helping in developing forms and templates for data collection
Coordinating with the ethics committee to ensure that the clinical trial is conducted in an ethical way.
Helping in setting up trial sites to ensure that the trials are conducted as per procedures and regulations
Helping in educating trial staff with new amendments
Monitoring of clinical trial sites at various clinical trial sites and review data for regulatory submissions
Report preparation as well as presentations for clinical trial sites
The responsibilities of a CRA are not limited to just one location or site, but involves meeting different people in different set-ups. By qualifications, CRAs generally hold a graduate or post-graduate degree in a medical science, nursing or life sciences. This is because, it helps with better relating to trial activities and better understanding of the protocol. The additional skills needed for a CRA includes:
- A clinical trial occurs in various stages and locations. Thus, a clinical research associate should be conversant with clinical trial management which is similar to managing a large project. Thus, good project management skills are vital to execute job responsibilities.
- Be an excellent communicator as a CRA plays a good role in communicating and educating different people. Thus, good verbal and written communication is necessary.
- Attention to detail and data analysis is important as regulators approve or reject drugs based on trial data. Therefore, attention to detail while reviewing all trial information is very important
- Good in organizing and time management skills as well as be able to multitask and make independent decisions.
- Skilled in IT and administrative skills Flexibility
The CRA thus plays a vital role in clinical trial conduct to maintain trial integrity. As a career it is a great one to adopt with good prospects. One can go a long way in life becoming one and the modules here would be a good kick off for it.
Interested in learning more? Check out our Monitoring 101 course HERE!