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CRA II / Senior CRA – Remote (Lithuania) – Single Sponsor

syneoshealth · LTU-Remote

Nauja Remote
Remote Senior 🇬🇧 English
Source document review

Darbo aprašymas

About the role

Syneos Health is seeking an experienced Clinical Research Associate (CRA II) or Senior CRA to support a single‑sponsor, Functional Service Provider (FSP) study. This home‑based position in Lithuania will involve remote and on‑site monitoring activities across the study lifecycle.

Key responsibilities

  • Perform site qualification, initiation, interim monitoring, management and close‑out visits, ensuring compliance with regulatory, ICH‑GCP and protocol requirements.
  • Conduct source document review, verify data entry in CRFs, and resolve queries both remotely and on‑site.
  • Manage investigational product inventory, reconciliation, storage, and dispensing according to protocol.
  • Maintain Investigator Site Files, reconcile with Trial Master Files, and support audit readiness.
  • Provide training, mentorship, and supervision to junior CRA staff as needed.
  • Participate in investigator meetings, sponsor interactions, and global monitoring team meetings.

Required profile

  • Bachelor’s degree or RN in a related field, or equivalent experience.
  • Strong knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements.
  • Excellent communication, presentation and interpersonal skills.
  • Willingness to travel up to 75% of the time, including on‑site visits.

Required skills

  • Good Clinical Practice (GCP) and ICH‑GCP compliance.
  • Experience with electronic data capture (EDC) systems.
  • Source document review and query resolution techniques.
  • Investigational product (IP) handling and inventory management.

Questions fréquentes

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Source : ats:workday

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LTU-Remote