Description
As a Senior Clinical Research Associate - Oncology at ICON Strategic Solutions in Miami, South Florida, you will work in a sponsor-dedicated model supported by ICON's global expertise.
You will perform site management activities to support Oncology site success and maintain inspection readiness.
Key responsibilities include:
- Conducting site management activities to support client site success and maintain inspection readiness
- Acting as primary contact and facilitating communication between client's clinical trial team and sites
- Performing remote and on-site monitoring visits to ensure data integrity and subject safety
- Assessing monitoring quality and training less experienced CRAs
- Documenting monitoring activities and submitting visit reports
- Managing site essential document collection and TMF reconciliation
- Supporting sites with IRB/EC submissions and confirming approvals
- Reviewing site KRI metrics and resolving issues
- Developing and implementing site CAPA plans
- Delivering training to ensure site compliance with protocol, SOPs, GCPs, and regulations
- Supporting regulatory inspections and site identification
- Leading site engagement initiatives and fostering relationships with key Oncology sites
Requirements:
- Bachelor's degree in a scientific field
- 5+ years of monitoring clinical trials independently
- 2+ years of monitoring solid tumor clinical trials
- 1+ year of early development oncology trial experience and/or Phase III Oncology trial experience
- Solid tumor clinical trial experience
- Experience with Veeva systems is highly preferred
- Demonstrated experience in site relationships and securing compliance
- Expertise in GxPs and Oncology monitoring techniques
- Experience collaborating with sites and supporting regulatory inspections
- Willingness to travel up to 50%
ICON offers a competitive and comprehensive total rewards package, including:
- Competitive base salary and performance-related incentives
- Health and wellbeing programs
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programs and wellbeing resources
- Learning and development opportunities