Clinical Research Associate (CRA II / Sr CRA I) – Remote, Slovakia
syneoshealth · SVK-Remote
Job description
About the role
Syneos Health is seeking experienced Clinical Research Associates to support sponsor‑dedicated studies in Slovakia. The role involves site qualification, initiation, monitoring, and close‑out activities, both on‑site and remotely, ensuring compliance with ICH‑GCP, regulatory requirements, and study protocols.
Key responsibilities
- Perform site qualification, initiation, interim monitoring, and close‑out visits, evaluating site performance and escalating issues.
- Review source documents, verify data entry in CRFs, resolve queries, and ensure electronic data capture compliance.
- Manage investigational product inventory, reconciliation, storage, and dispensing according to protocol.
- Maintain Investigator Site Files, reconcile with Trial Master Files, and document activities through letters and reports.
- Support subject recruitment, retention, and awareness strategies, and track observations in study tracking systems.
Required profile
- Bachelor’s degree or RN in a related field, or equivalent experience.
- Strong knowledge of Good Clinical Practice, ICH guidelines, and applicable regulatory requirements.
- Excellent communication, presentation, and interpersonal skills.
- Willingness to travel up to 75% of the time.
Required skills
- Good Clinical Practice (GCP) and ICH guideline expertise.
- Site monitoring and management experience.
- Investigational product handling and documentation.
- Source document review and query resolution.
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Published 21 hours ago
Expires 1 month from now
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syneoshealth
SVK-Remote
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