National Occupational Standard for Clinical Research Associate

Definition of Occupation

The Clinical Research Associate (CRA) (This role is also known as a Clinical Trial Monitor) works at Contract Research Organizations (CROs) or sponsor organizations (e.g., pharmaceutical and biotechnology companies) and holds either permanent, full-time, or contract positions. The CRA frequently visits study sites, which involves a significant amount of travelling. They must be able to consistently deliver accuracy in their work despite time constraints, and they must be able to work well with others while under pressure. They also leverage their scientific background to meet the study sponsor’s objectives. The CRA may come from a wide variety of backgrounds. For example, some are medical professionals (e.g., foreign doctors, nurses, study coordinators) while others may have a degree in clinical research, life/health sciences, medical technology, health information management, biology, etc.

The CRA is responsible for ensuring that the rights and wellbeing of participants are protected, the integrity of the study is maintained, all study data and documentation are complete, accurate, and verified, and site staff are conducting the study per study documents, local standard operating procedures (SOPs), local/central Research Ethics Board (REB) requirements, International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, and applicable regulatory requirements. They have the responsibility of ensuring that the sites are well prepared for audits and inspections.

In the case of deviations, the CRA works with the site to understand the root cause and implement solutions to solve the current issues or problems. They ensure processes are implemented to prevent the errors from being repeated.

During the study’s start-up phase, the CRA may conduct the pre-study visits (PSVs), also known as qualification visits (QVs), as well as the site-initiation visits (SIVs). They also may create Investigator Site Files (ISFs) for the sites. Once the site has been activated (i.e., ready and approved to start enrolling participants), the CRA is responsible for conducting monitoring visits, writing visit reports, performing source data verification (SDV), training site staff, and ensuring that the sites’ source documentation and essential documents are filed appropriately. The CRA ensures that the document management plan is followed and that all required study related documentation is reviewed and uploaded to the paper/electronic Trial Master File (eTMF).

How to use a National Occupational Standard 

View summary of NOS profile here: Clinical Research Associate – National Occupational Standard Summary