Our client - international clinical, regulatory and pharmacovigilance solution provider is looking for Clinical Research Associate experienced with independent monitoring in full cycle

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

·       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

Company offers:

·       Professional growth and career opportunities

·       Supportive work environment

·       Additional benefits (bonus system, additional health insurance and etc.)

·       International team