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CRA II / Senior CRA – Remote in Lithuania

syneoshealth · LTU-Remote

Nauja Remote
Remote Senior 🇬🇧 English
Good Clinical Practice ICH Guidelines Electronic Data Capture Source document review

Darbo aprašymas

About the role

Syneos Health is seeking an experienced Clinical Research Associate (CRA II or Senior CRA) to work remotely from Lithuania on a single‑sponsor (FSP) real‑world late‑phase study. You will support the full study lifecycle, ensuring compliance with regulatory standards and high‑quality data collection.

Key responsibilities

  • Perform site qualification, initiation, monitoring, management and close‑out visits remotely or on‑site, ensuring adherence to ICH‑GCP, GPP and protocol requirements.
  • Review source documents, verify data entry in CRFs, resolve queries and ensure electronic data capture compliance.
  • Manage investigational product inventory, reconciliation, storage, dispensing and documentation.
  • Maintain Investigator Site Files, reconcile with Trial Master Files and support audit readiness.
  • Provide training, mentorship and supervision to junior CRA staff and collaborate with central monitoring associates.

Required profile

  • Bachelor’s degree or RN in a related field, or equivalent education and experience.
  • Knowledge of Good Clinical Practice, ICH Guidelines and applicable regulatory requirements.
  • Willingness to travel up to 75% of the time as needed.
  • Strong communication, presentation and interpersonal abilities.

Required skills

  • Good Clinical Practice (GCP) and ICH guideline expertise.
  • Electronic Data Capture (EDC) systems proficiency.
  • Investigational product (IP) handling and inventory management.
  • Source document review and data verification.
  • Computer literacy and ability to adopt new technologies.

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Source : ats:workday

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LTU-Remote