Clinical Research Associate II – Functional Service Provider

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, ensuring compliance with ICH‑GCP, Good Pharmacoepidemiology Practice and protocol requirements.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, and close‑out visits (on‑site or remotely) and document compliance with regulatory and protocol standards.
• Review source documents, verify data entered in case report forms, and resolve queries within agreed timelines.
• Manage investigational product inventory, reconciliation, storage, and dispensing according to protocol.
• Maintain Investigator Site Files, reconcile with Trial Master Files, and ensure proper archiving of essential documents.
• Support subject recruitment, retention, and awareness strategies, and document activities through trip reports and communication logs.
• Collaborate with project teams, act as liaison with site personnel, and contribute to audit readiness and training of junior staff.

Required profile

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

Required skills

• Proficiency with electronic data capture systems and case report form (CRF) review.
• Understanding of investigational product handling and documentation.
• Good computer skills and ability to adopt new technologies.