Job description - Senior Clinical Research Associate
Alternative job titles
Senior (Site)Monitor Senior Clinical Research Scientist
Senior Clinical Trial Monitor Sr. CRA
Senior Clinical Research Executive CRA III
Description
A Senior Clinical Research Associate (S)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 (S)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 an (S)CRA can work. 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 position generally requires extensive experience as a CRA (level 1 and 2) and special knowledge in a therapeutic area. The candidate should have knowledge of ICH-GCP and a strong interest in clinical research. Professional use of the English language; both written and verbal.
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 problems reacting quickly and effectively to resolve them
- Conscientious and precise delivery of work even when under pressure
- Quickly able to understand and execute new complex tasks
Tasks
- Act as the main line of communication between the sponsor and the investigator. and maintain contact to marketing and sales department
- Project coordination, planning and logistics, including overview of budget and timelines
- 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
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