Biomapas
201 - 500 employees
🧬 Biotechnology
💊 Pharmaceuticals
⚕️ Healthcare Insurance
Biotechnology • Pharmaceuticals • Healthcare Insurance
Biomapas is a comprehensive outsourcing solution provider catering to the global life science sector. The company acts as a strategic partner for biopharmaceutical and medical device companies, offering extensive clinical research services worldwide. Biomapas covers the entire product lifecycle from regulatory compliance to pharmacovigilance and medical information. The company operates across various regions including Europe, CIS, EAEU, MENA, LATAM, and the US, ensuring high-quality, efficient, and cost-effective methodologies to deliver superior service and strategic advantages. With a focus on clinical trials, pharmacovigilance, and regulatory affairs, Biomapas is equipped to navigate complex regulatory environments and manage clinical trial data effectively, contributing to clients' commercial success.
Clinical Research Associate
🔥 0 minutes ago
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Biomapas
201 - 500 employees
🧬 Biotechnology
💊 Pharmaceuticals
⚕️ Healthcare Insurance
Biotechnology • Pharmaceuticals • Healthcare Insurance
Biomapas is a comprehensive outsourcing solution provider catering to the global life science sector. The company acts as a strategic partner for biopharmaceutical and medical device companies, offering extensive clinical research services worldwide. Biomapas covers the entire product lifecycle from regulatory compliance to pharmacovigilance and medical information. The company operates across various regions including Europe, CIS, EAEU, MENA, LATAM, and the US, ensuring high-quality, efficient, and cost-effective methodologies to deliver superior service and strategic advantages. With a focus on clinical trials, pharmacovigilance, and regulatory affairs, Biomapas is equipped to navigate complex regulatory environments and manage clinical trial data effectively, contributing to clients' commercial success.
📋 Description
• Join our dynamic team at Biomapas as a Clinical Research Associate (CRA) in Ukraine. • Your role will be crucial in overseeing clinical trials and ensuring that they are conducted in compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards. • 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 • Prepare clinical trial documents and store, archive correspondence • Negotiate study budgets with potential investigators/sites, assist in agreements
🎯 Requirements
• University degree in Life Science field • Fluent English and local language • Independent monitoring experience as a 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
🏖️ Benefits
• Professional growth and career opportunities • International team and environment • Bonus based on annual performance • Personal accident and business trip insurance • Additional health insurance • Remote/home based • Complimentary health and wellness benefits, such as influenza vaccines • Rewarding referral policy • Workplace establishment allowance (fully remote) • Team building, global meetings, B active events
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