Join our global team as a (Senior) Clinical Research Associate (CRA) in Poland.
(Senior) Clinical Research Associate (CRA) is responsible for coordinating and overseeing the execution of studies and clinical trials at investigational sites.
Position is in Poland.
• 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
• 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 of local regulations and 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
Benefits of being a part of our team:
• Professional growth and career opportunities
• Supportive work environment
• Additional benefits (bonus system, additional health insurance and etc.)
• International team
Biomapas is a functional and full outsourcing solution provider to the global life science industry, with key expertise in Clinical Trials, Regulatory Affairs, Pharmacovigilance and Medical Information. With headquarters in Lithuania and offices in Switzerland, Russia, Georgia, Ukraine, Poland, Kazakhstan and Sweden, Biomapas operations are spread over 5 continents, concentrated in Europe, Russia and former CIS region.