Job description - Clinical Research Associate (CRA)
Alternative job titles
(Site)Monitor Clinical Research Scientist
Clinical Trial Monitor Clinical Research Executive
CRA I CRA II
Junior CRA
Description
A Clinical Research Associate (CRA) has an important task within the clinical trial process. He or she has the responsibility to verify that the rights and well-being of human subjects are protected and that the reported trial data are accurate, complete, and verifiable from source documents. Most importantly, the CRA makes sure that the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirement. There are various levels at which a CRA can work. Examples of this are Junior, level 1 and 2 (also known as Senior CRA (S)). These differing levels determine the tasks and responsibilities to be carried out, and are often experience dependent.
Qualifications
The most typical candidate for a CRA position possesses a bio-medical related scientific degree, which can vary from a bachelor, master and nursing qualifications. The candidate should have knowledge of ICH-GCP and a strong interest in clinical research.
Professional use of the English language; both written and oral
Competencies
- Open and clear communicator
- Confident and influential approach
- Make independent choices and take responsibility for own actions
- Understand the needs of others
- Coordination and planning of budgets, people and time management
- Recognise potential obstacles and work to resolve them within set timelines
- Conscientious and precise delivery of work even when under pressure
Tasks
- Act as the main line of communication between the sponsor and the investigator
- Verifying that all research staff, facilities and investigational products have adequate qualifications and resources and these remain adequate throughout
- Responsible for the safety and proper conduct throughout the trial
- Verifying that the investigator follows the approved protocol and all GCP procedures
- Verifying that source data/documents and other trial records are accurate, complete, and maintained
- Adverse events, concomitant medications, and inter current illnesses are reported in accordance with the protocol on the CRFs
- Communicating deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator