Senior Clinical Research Associate (Remote, Lithuania)
Syneos Health
Darbo aprašymas
About the role
Syneos Health is seeking an experienced Clinical Research Associate (CRA) to work remotely from Lithuania on a single‑sponsor Functional Service Provider (FSP) project. The role involves overseeing site activities throughout the study lifecycle, ensuring compliance with ICH‑GCP, regulatory requirements and study protocols.
Key responsibilities
- Perform site qualification, initiation, monitoring, management and close‑out visits, both on‑site and remotely.
- Review source documents, verify data entered in case report forms, and resolve queries within agreed timelines.
- Manage investigational product inventory, reconciliation, storage, and dispensing according to protocol.
- Maintain Investigator Site Files, reconcile with Trial Master Files, and ensure proper archiving of essential documents.
- Support subject recruitment, retention and awareness strategies, and track observations and action items.
- Collaborate with central monitoring, sponsor, and regulatory teams, and participate in investigator meetings and global project calls.
Required profile
- Bachelor’s degree or RN in a related field, or equivalent experience.
- Strong knowledge of ICH‑GCP guidelines and applicable regulatory requirements.
- Ability to travel up to 75% of the time, if required.
- Excellent communication, presentation and interpersonal skills.
- Critical thinking and ability to adapt quickly to changing priorities.
Required skills
- Proficiency with Electronic Data Capture (EDC) systems.
- Experience using clinical trial monitoring software and source document review tools.
- Solid understanding of Good Clinical Practice (GCP) and Good Pharmacoepidemiology Practices (GPP).
What we offer
- Career development and progression opportunities with supportive line management.
- Technical and therapeutic area training, peer recognition and total rewards program.
- Inclusive culture that encourages authenticity and collaboration.
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Syneos Health