Part‑time Clinical Research Associate (0.5 FTE) – Remote, Lithuania
syneoshealth · LTU-Remote
Darbo aprašymas
About the role
Syneos Health is seeking a part‑time Clinical Research Associate to support site qualification, monitoring and close‑out activities for real‑world late‑phase studies. The role is home‑based in Lithuania and will involve both remote and occasional on‑site work.
Key responsibilities
- Perform site qualification, initiation, interim monitoring, management and close‑out visits, ensuring compliance with regulatory, ICH‑GCP and Good Pharmacoepidemiology Practice guidelines.
- Review source documents, verify data entry 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.
- Document activities through letters, trip reports and logs, and support recruitment and retention strategies.
Required profile
- Bachelor’s degree or RN in a related field, or equivalent experience.
- Knowledge of Good Clinical Practice, ICH‑GCP guidelines and relevant regulatory requirements.
- Excellent communication, presentation and interpersonal skills.
- Willingness to travel up to 75% of the time as required.
Required skills
- Good Clinical Practice (GCP) and ICH/GCP knowledge.
- Electronic data capture (EDC) systems proficiency.
- Source document review and query resolution.
- Investigational product handling and inventory management.
- Strong computer skills and ability to adopt new technologies.
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Paskelbta prieš 6 valandas
Baigia galioti 1 mėnuo nuo dabar
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syneoshealth
LTU-Remote
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