Senior Clinical Research Associate (Level I)

About the role

Join a global team that supports leading pharmaceutical and biotech companies across more than 100 countries. As a Senior Clinical Research Associate (Level I), you will lead remote and on‑site monitoring activities, ensuring trials are conducted in compliance with protocols, ICH‑GCP, and local regulations.

Key responsibilities

• Perform risk‑based monitoring visits, applying root‑cause analysis to identify and correct site process failures.
• Verify data accuracy through source data verification (SDR), source data review (SDV), and case report form (CRF) review.
• Assess investigational product inventory and documentation.
• Document observations, generate reports, and communicate findings to clinical management.
• Maintain regular contact with sites to ensure protocol adherence and timely data entry.
• Support investigator payment processes and participate in investigator meetings.
• Provide trial status updates and ensure study systems (CTMS) are current.
• Identify and qualify new investigative sites in collaboration with the client.

Required profile

• Proven experience in clinical monitoring and site management.
• Strong knowledge of ICH‑GCP guidelines, regulatory requirements, and SOPs.
• Ability to conduct both remote and on‑site visits.
• Excellent analytical, problem‑solving, and communication skills.
• Detail‑oriented with a focus on audit readiness and data integrity.

Required skills

• Clinical Trial Management System (CTMS) proficiency
• Familiarity with ICH‑GCP standards

What we offer

• Opportunity to work on high‑impact clinical trials for top pharma and biotech sponsors.
• Collaborative, global environment with professional development support.