Clinical Research Associate II – Site Management

About the role

The Clinical Research Associate II (CRA II) will support real‑world late‑phase studies from site identification through close‑out, ensuring compliance with regulatory and protocol requirements. This position involves both on‑site and remote monitoring activities.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, management and close‑out visits, ensuring ICH‑GCP and protocol compliance.
• Review source documents, verify data entry in CRFs, resolve queries, and maintain accurate Investigator Site Files.
• Manage investigational product inventory, reconciliation, storage, and dispensing according to protocol.
• Document activities through letters, trip reports, and logs; support recruitment, retention, and audit readiness.
• Collaborate with study sites, central monitoring associates, sponsors, and internal teams; attend investigator and sponsor meetings.

Required profile

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

Required skills

• Good Clinical Practice (GCP) / ICH guideline knowledge.
• Proficiency with electronic data capture systems and source document review.
• Strong computer skills and ability to adopt new technologies.