Senior Clinical Research Associate

We are seeking an experienced Senior Clinical Research Associate (CRA) to independently manage and monitor clinical trial sites throughout the full study lifecycle, from start-up through close-out. This is a highly autonomous, field-based role requiring an experienced monitor who can take ownership of site activities with minimal supervision while ensuring the highest standards of compliance, data quality, and site performance.

Independently conduct:

• Site Qualification Visits (SQVs)
• Site Initiation Visits (SIVs)
• Interim Monitoring Visits (IMVs)
• Close-Out Visits (COVs)
• Serve as the primary point of contact for assigned clinical trial sites.
• Ensure compliance with study protocols,
  ICH-GCP
  , FDA regulations, and applicable SOPs.
• Perform source data verification, resolve site queries, and maintain data integrity and quality.
• Manage Investigator Site Files (ISF) and support Trial Master File (TMF) documentation to maintain inspection readiness.
• Conduct investigational product accountability and reconciliation activities.
• Provide ongoing site training, support, and guidance throughout the study lifecycle.
• Complete monitoring reports, follow-up letters, and visit documentation within required timelines.
• Identify, escalation, and support resolution of site issues and compliance risks.

• Bachelor's degree in Life Sciences or a related scientific discipline.
• Minimum 5 years of CRA monitoring experience within clinical research.
• Proven experience independently managing sites across the full clinical trial lifecycle.
• Strong knowledge of:
• ICH-GCP
• FDA regulations
• Clinical trial operations
• eCRF and electronic data capture systems
• Demonstrated ability to manage multiple sites and priorities simultaneously.
• Valid driver's licence required.
• Up to 100% travel required, including air and ground travel.