Senior Clinical Research Associate
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Job Description
Senior Clinical Research Associate overseeing oncology Phase I trials for ICON, a global clinical research organisation. Managing investigative sites, monitoring data integrity, and ensuring patient safety and inspection readiness.
Responsibilities:
- Perform investigative site management and monitoring activities throughout the clinical trial lifecycle
- Support the client's Oncology clinical trials to ensure data integrity, subject safety, and inspection readiness
- Perform site management activities and maintain continuous inspection readiness
- Act as the primary contact between the client's clinical trial team and sites
- Perform remote and on-site monitoring/co-monitoring visits, including qualification, initiation, interim monitoring, and close-out visits
- Perform oversight activities to assess monitoring quality and train or mentor less experienced CRAs
- Document monitoring activities and submit or approve visit reports
- Manage site essential document collection and TMF reconciliation with site files
- Support local IRB/Ethics Committee submissions and confirm approvals
- Review site Key Risk Indicator metrics, issues, and action items to detect trends and ensure prompt resolution
- Determine root causes and develop or implement site CAPA plans
- Deliver training on protocols, SOPs, GCPs, and regulations
- Support sites and the client during regulatory inspections
- Contribute to site identification, feasibility, qualification, and activation activities
- Lead site engagement initiatives and foster relationships with key Oncology sites and networks
Requirements:
- Bachelor's degree; scientific field preferred
- 5+ years monitoring clinical trials and independently conducting on-site and remote monitoring visits
- At least 2 years monitoring solid tumor clinical trials
- 1+ years of early development oncology trial experience and/or Phase III Oncology trial experience
- Solid tumor clinical trial experience required
- Experience utilizing Veeva systems highly preferred
- Demonstrated experience developing and maintaining site relationships and securing compliance
- Expertise in GxPs and Oncology monitoring techniques, including Risk-Based Monitoring, and terminology
- Experience collaborating with sites from initial engagement through close-out phases
- Experience activating sites
- Experience training site staff
- Experience supporting sites and/or sponsors in regulatory inspections
- Experience working within a Functional Services or in-house monitoring model preferred
- Willingness to travel up to 50%
- Legal right to work in the country where the role is based
Benefits:
- Competitive base salary
- Performance related incentives
- Medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
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