Overview
Join our global team as a (Senior) Clinical Research Associate (CRA) in Ukraine. Clinical Research Associate (CRA) is responsible for coordinating and overseeing the execution of studies and clinical trials at investigational sites. Role is combined with office and home-based in Kyiv, Ukraine. CV 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 and submission to regulatory authorities Prepare clinical trial documents and store, archive correspondence Negotia
Full job description
Description
Full Job Description
Join our global team as a (Senior) Clinical Research Associate (CRA) in Ukraine.
Clinical Research Associate (CRA) is responsible for coordinating and overseeing the execution of studies and clinical trials at investigational sites.
Role is combined with office and home-based in Kyiv, Ukraine.
CV 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 and submission to regulatory authorities
- Prepare clinical trial documents and store, archive correspondence
- Negotiate study budgets with potential investigators/sites, assist in agreements
- Provide monitoring visits and site management
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
- Hybrid mode of work
- Complimentary health and wellness benefits, such as influenza vaccines
- Rewarding referral policy
- Workplace establishment allowance (fully remote)
- Team building, global meetings, B active events
Qualifications And Requirements
Mid-Senior level
Requirements & qualifications
Mid-Senior level
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