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 coordinate and execute monitoring activities, ensuring trials are conducted according to protocol, ICH‑GCP and regulatory standards.

Key responsibilities

• Perform risk‑based on‑site and remote monitoring visits, applying root‑cause analysis to identify and resolve site process failures.
• Verify source data (SDR/SDV) and review case report forms (CRF) for accuracy and completeness.
• Assess investigational product inventory and documentation.
• Document findings in reports and letters, escalating deficiencies to clinical management and following through to resolution.
• Maintain regular communication with sites to ensure protocol compliance and timely data capture.
• Support investigator payment processes and contribute to investigator meetings.
• Update study systems (CTMS) and perform quality checks on generated reports.
• Identify and qualify potential investigative sites in collaboration with the client.

Required profile

• Senior‑level experience in clinical monitoring within CRO or sponsor environments.
• Strong knowledge of ICH‑GCP, regulatory requirements and SOPs.
• Proven ability to conduct root‑cause analysis and implement corrective actions.
• Excellent written communication for timely reporting.

Required skills

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