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Clinical Research Associate II – Remote (Lithuania)

syneoshealth · LTU-Remote

Nauja Remote
Remote Mid 🇬🇧 English
ICH guidelines Source document review

Darbo aprašymas

About the role

The Clinical Research Associate II will support site qualification, initiation, monitoring and close‑out activities for real‑world late‑phase studies, ensuring compliance with regulatory and protocol requirements.

Key responsibilities

  • Perform site qualification, initiation, interim monitoring, and close‑out visits (on‑site or remotely) following ICH‑GCP and Good Pharmacoepidemiology Practice.
  • Review source documents, verify data entry in CRFs, resolve queries and ensure electronic data capture compliance.
  • Manage investigational product inventory, reconciliation, and dispensing according to protocol.
  • Document activities through letters, reports, and logs; support recruitment, retention and audit readiness.
  • Collaborate with sponsor affiliates, medical science liaisons and local staff; may train junior staff.

Required profile

  • Bachelor’s degree or RN in a related field, or equivalent experience.
  • Knowledge of Good Clinical Practice and ICH guidelines.
  • Excellent communication and interpersonal skills.
  • Willingness to travel up to 75% of the time.

Required skills

  • Good Clinical Practice (GCP) knowledge
  • ICH guideline familiarity
  • Electronic data capture systems
  • Source document review
  • Computer proficiency and ability to adopt new technologies

Questions fréquentes

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Source : ats:workday

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