Clinical Research Associate I (CRA Level I)

About the role

We are looking for a Clinical Research Associate I to join our global clinical monitoring team. The CRA will support the execution of clinical trials by performing remote and on‑site visits, ensuring compliance with protocols, regulations and ICH‑GCP standards.

Key responsibilities

• Conduct risk‑based monitoring visits (remote or on‑site) to assess protocol adherence, regulatory compliance and data quality.
• Perform source data verification (SDR), source data review (SDV) and case report form (CRF) review as required.
• Assess investigational product inventory and documentation.
• Document findings in monitoring reports and correspondence, escalating issues to clinical management.
• Maintain regular communication with investigative sites to resolve findings and ensure timely data capture.
• Participate in investigator payment processing and investigator meetings.
• Assist in site initiation, trial close‑out and retrieval of trial materials.

Required profile

• Strong analytical mindset with ability to apply root cause analysis and critical thinking.
• Excellent written communication skills for timely report generation.
• Detail‑oriented and able to work independently or within a project team.

Required skills

• Knowledge of ICH‑GCP guidelines and applicable regulatory requirements.
• Experience with source data verification (SDR), source data review (SDV) and case report form (CRF) processes.
• Proficiency in conducting root cause analysis and implementing corrective actions.