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.
Role is combined with office and home-based in Ukraine. All CV's needs to be submitted in English language.
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
- Prepare clinical trial documents and store, archive correspondence
- Negotiate study budgets with potential investigators/sites, assit 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
Biomapas is a functional and full outsourcing solution provider to the global life science industry. As a trusted partner for biopharmaceutical, medical device, cosmetics, and food supplement companies, we have one-stop-shop clinical research capabilities in high recruiting countries, delivering regulatory and pharmacovigilance excellence across Europe, CIS, MENA, and LATAM regions through the entire product lifecycle. Our in-house experience combined with a hands-on mindset allows for tailored solutions to complicated challenges that emerge on your path to commercialization. Our professionals execute your projects efficiently, cost-effectively and aspire to partner with you and become an integral part of your team from Early Development to Commercial success. We keep our promises. Always. Social media privacy policy: bit.ly/privacy-biomapas
Key team members
Tomaz Trcek
Martijn van de Leur
Valdis Tocs
Inga Garliauskiene
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