Description
As a Senior Clinical Research Associate - Oncology - Texas at ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON's global expertise.
In this role, you will perform site management activities to support the client's Oncology site success and maintain a continuous state of inspection readiness.
Key responsibilities include:
- Acting as the primary contact and facilitating efficient communications between the client's clinical trial team and the sites
- Performing remote and on-site monitoring/co-monitoring visits to ensure data integrity and subject safety in the client's trials
- Managing site essential document collection and TMF reconciliation with site files
- Supporting sites with local Institutional Review Board (IRB)/Ethics Committee (EC) submissions and confirming approvals
- Regularly reviewing site Key Risk Indicator (KRI) metrics, issues, and action items to detect trends and ensure prompt resolution
- Independently determining root causes and developing/implementing site Corrective Action and Preventive Action (CAPA) plans
- Delivering training to ensure sites comply with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and regulations
- Supporting sites and the client's regulatory inspections
- Contributing to site identification, driving site feasibility and qualification progress, and supporting site activation activities
- Leading site engagement initiatives and fostering relationships with key Oncology sites and networks
Requirements:
- Bachelor's degree in a scientific field
- 5+ years of experience monitoring clinical trials independently, conducting on-site and remote monitoring visits
- At least 2 years of experience monitoring solid tumor clinical trials
- 1+ year of experience in early development oncology trials and/or Phase I or Phase III Oncology trials
- Solid tumor clinical trial experience is required
- Experience utilizing Veeva systems is highly preferred
- Demonstrated experience developing/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, training site staff, and supporting sites and/or sponsors in regulatory inspections
- Willingness to travel up to 50%
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development, which may include:
- Competitive base salary and performance-related incentives
- Health and wellbeing programmes, including 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