Clinical Research Associate II – Remote (Lithuania)

About the role

The Clinical Research Associate II (CRA II) will support real‑world late‑phase studies across Lithuania, performing site qualification, monitoring, and close‑out activities either on‑site or remotely. You will ensure compliance with ICH‑GCP, Good Pharmacoepidemiology Practice and protocol requirements while collaborating with investigators and internal teams.

Key responsibilities

• Conduct site qualification, initiation, interim monitoring, and close‑out visits, ensuring regulatory and protocol compliance.
• Review source documents, verify data entry in CRFs, and resolve queries to closure within timelines.
• Manage investigational product inventory, reconciliation, storage, and dispensing according to protocol.
• Document activities via letters, trip reports, and logs; support recruitment, retention, and audit readiness.
• Collaborate with central monitoring associates, attend investigator meetings, and train junior staff as needed.

Required profile

• Bachelor’s degree or RN in a related field, or equivalent experience.
• Knowledge of Good Clinical Practice/ICH Guidelines and relevant 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.
• Electronic data capture (EDC) systems proficiency.
• Source document review and data verification.
• Investigational product handling and inventory management.