Clinical Research Associate (CRA)

Responsibilities: 

Study site monitoring and management (site selection, initiation, monitoring and close-out visits)  

Perform feasibilities and support start-up phase 

Create and maintain required study documentation (site management, monitoring, etc.) 

Ensure that clinical trials are conducted according to requirements (protocol, ICH-GCP, etc.) 

Administer protocol and related study training to assigned sites 

Perform regulatory document review and submission to regulatory authorities 

Prepare clinical trial documents and store, archive correspondence 

Negotiate study budgets with potential investigators/sites, assit in agreements

Provide monitoring visits and site management 

Requirements: 

University degree in Life Science field 

Fluent English language 

2-5 year’s experience as CRA (independent monitoring) 

In depth therapeutic and protocol knowledge 

Deep knowledge in clinical research regulatory requirements (GCP and ICH) 

Excellent skills in MS Office, EDC and other clinical trial related systems and platforms 

Attention to detail and time-management skills