Clinical Research Associate II – Site Management

About the role

The Clinical Research Associate II (CRA II) will support site activities throughout the study lifecycle, from qualification to close‑out, ensuring compliance with regulatory and protocol requirements.

Key responsibilities

• Perform site qualification, initiation, monitoring, management and close‑out visits on‑site or remotely.
• Review source documents, verify data entry in CRFs, 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 archiving compliance.
• Document activities through letters, trip reports, and logs; support recruitment, retention and awareness strategies.
• Act as liaison with site personnel, attend investigator and sponsor meetings, and contribute to audit readiness.

Required profile

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

Required skills

• Good computer skills and ability to adopt new technologies.
• Understanding of electronic data capture systems and query resolution techniques.
• Familiarity with regulatory requirements and company SOPs.

What we offer

• Career development and progression opportunities.
• Supportive line management, technical and therapeutic area training.
• Inclusive culture with peer recognition and total rewards program.