Clinical Research Associate II – Remote (Romania)

About the role

The Clinical Research Associate II (CRA II) will support site qualification, initiation, monitoring and close‑out activities for real‑world late‑phase studies in Romania. Working remotely, you will ensure compliance with ICH‑GCP, local regulations and study protocols while collaborating with sponsors, medical science liaisons and internal teams.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, and close‑out visits (on‑site or remote) ensuring regulatory and protocol compliance.
• Review informed consent processes, source documents, and case report forms for accuracy and completeness.
• Manage investigational product inventory, reconciliation, and compliance with labeling and storage requirements.
• Document activities through letters, trip reports and logs; support recruitment, retention and audit readiness.
• Collaborate with central monitoring associates, attend investigator meetings and provide training to site staff.

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 as needed.

Required skills

• Good Clinical Practice (GCP) and ICH guideline expertise.
• Electronic Data Capture (EDC) systems proficiency.
• Source document review and query resolution.
• Investigational product handling and inventory management.