About Clinical Research

Example of a career path: being a CRA

Responsibilities

Clinical Research Associates (CRAs) are part of the Clinical Operations group. Working as a CRA means having high and noble responsibilities. CRAs have the very critical role of monitoring clinical trials to ensure the rights and well-being of human subjects are protected, the reported trial data are accurate, complete, and verifiable and that the conduct of the trial is in compliance with the study protocol, GCP and the applicable regulatory requirements.

Travels

CRAs travel a substantial amount of their time as they need to visit research centres that conduct clinical trials. This can be at a local, national and even international level.

Various tasks

CRA life can be very exciting as no two days are alike. Typically, CRAs are involved in:

  • Identifying suitable research centres to conduct clinical trials 
  • Training participating centres to ensure their staff is aware of their responsibilities and is familiar with trial documents, procedures and timelines
  • Monitoring trials by visiting participating centres periodically to ensure compliance with GCP, the protocol, the procedures and the regulatory requirements
  • Closing participating centres at the end of clinical trials 
  • Maintaining trial documentation throughout the duration of the study

Career path

The usual career path for CRAs is to start in an entry level position such as Clinical Trials Assistant (CTA), In-House CRA, Project Scientist/Coordinator, data coordinator, regulatory associate or site coordinator, to name but a few. It is relatively unusual for a graduate with no relevant prior experience to go straight into CRA work, although some companies will employ recent graduates with the necessary personal skills. After 1 or 2 years in these positions, people progress to increasing levels of seniority and become CRA 1, then CRA 2, sometimes also CRA 3 and finally Senior CRA.

The next level of responsibilities would be Lead CRA, CRA Manager, Team Leader or Junior Project Manager where part of the role is to lead other clinical research professionals and manage certain aspects of clinical studies. It is also possible for an experienced CRA to leave the Clinical Operations career path to embrace other paths such as quality assurance and auditing, regulatory affairs, etc.