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Clinical Research Associate is responsible for monitoring clinical trials and ensuring compliance with regulatory requirements, study protocols, and standard operating procedures (SOPs).
This is a position for the potential activities in Latvia, working in close collaboration Clinical Operations team.
You have energy and motivation to work in a team and to gain more experience?
Submit your CV in the English language for consideration.
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
- Bachelor's degree in Life Sciences, Nursing, or related field
- Fluent English language
- Minimum 2 years of experience as a Clinical Research Associate (CRA) in a pharmaceutical or clinical research organization
- In depth therapeutic and protocol knowledge
- Deep knowledge in clinical research regulatory requirements (GCP and ICH)
- Proficient in electronic data capture systems, and familiarity with Microsoft Office Suite
- Attention to detail and time-management skills
Key Skills
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