Senior Clinical Research Associate (Level I)

About the role

Join a global CRO team that supports leading pharmaceutical and biotech companies across more than 100 countries. As a Senior Clinical Research Associate (Level I) you will oversee remote and on‑site monitoring visits, ensuring each trial complies with the approved protocol, ICH‑GCP guidelines and sponsor SOPs.

Key responsibilities

• Conduct risk‑based monitoring visits, applying root‑cause analysis to identify and correct site process failures.
• Perform source data verification (SDV), source data review (SDR) and CRF review to guarantee data accuracy.
• Assess investigational product inventory and documentation.
• Document observations in reports and letters, escalating deficiencies to clinical management.
• Maintain regular communication with sites to resolve outstanding issues and ensure timely data capture.
• Provide trial status updates and progress reports to the Clinical Team Manager.
• Update study systems such as the Clinical Trial Management System (CTMS) and perform QC checks on generated reports.
• Participate in investigator meetings and assist with investigator payment processes.

Required profile

• Senior‑level experience in clinical monitoring and site management.
• Strong understanding of ICH‑GCP, regulatory requirements and sponsor SOPs.
• Proven ability to work independently, prioritize tasks and manage multiple sites.
• Excellent written communication skills for report generation and issue escalation.

Required skills

• ICH‑GCP compliance
• Risk‑based monitoring
• Root‑cause analysis
• Source Data Verification (SDV)
• Source Data Review (SDR)
• CRF review
• Clinical Trial Management System (CTMS) usage