Clinical Research Associate II / Senior CRA

About the role

The Clinical Research Associate II (CRA II) / Senior CRA supports site qualification, initiation, monitoring, and close‑out activities for clinical and real‑world studies, ensuring compliance with regulatory and protocol requirements.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, and close‑out visits on‑site or remotely, ensuring adherence to ICH‑GCP, Good Pharmacoepidemiology Practice and protocol.
• Review source documents, verify data entry in CRFs, resolve queries, and ensure electronic data capture compliance.
• Manage investigational product inventory, reconciliation, storage, and dispensing according to protocol.
• Document activities through trip reports, letters, and logs; support recruitment, retention, and site training.
• Collaborate with project teams, act as liaison with site personnel, and contribute to audit readiness.

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.
• Ability to travel up to 75% of the time.

Required skills

• Good Clinical Practice (GCP) and ICH guideline expertise
• Source document review and data verification
• Electronic Data Capture (EDC) systems proficiency
• Investigational product (IP) management
• Query resolution techniques