About this role
Job title: Senior Clinical Research Associate - Oncology
About the Role Senior Clinical Research Associate (Oncology) based in New York. You will manage Oncology site activities, monitor trials, ensure data integrity and subject safety, and support inspections and regulatory submissions for our client trials.
What You'll Do
- Perform site management activities to support Oncology site success and maintain inspection readiness
- Conduct remote and on-site monitoring (Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits, Close-Out Visits) to ensure data integrity and subject safety
- Oversee monitoring quality, train/mentor less experienced CRAs, document activities and submit visit reports
- Manage site essential documents and TMF reconciliation with site files
- Support IRB/EC submissions and confirm approvals
- Review site Key Risk Indicator (KRI) metrics and drive action items to resolution
- Identify root causes and implement CAPA plans
- Provide training to ensure compliance with protocol, SOPs and GCPs
- Support regulatory inspections and sponsor/client inspections
- Contribute to site identification, feasibility, qualification, activation; lead site engagement with Oncology sites and networks
What We're Looking For
- Bachelor's degree (scientific field preferred)
- 5+ years of independent on-site and remote monitoring; solid tumor trial experience; early development trial experience (1+ year)
- Solid tumor clinical trial experience required
- Experience with Veeva systems highly preferred
- Demonstrated ability to develop/maintain site relationships and ensure compliance
- Expertise in GxPs and Oncology monitoring techniques (including Risk-Based Monitoring)
- Experience collaborating with sites from initial engagement through close-out; site activation
- Training site staff and supporting sites/sponsors in regulatory inspections
- Experience in Functional Services (or in-house) monitoring model preferred
- Willing to travel up to 50%
Nice to Have
- Veeva systems experience (if not already stated above) and oncology network engagement
Compensation & Benefits
- Salary range: $110,520.00-$138,150.00 annually
- Bonus, stock, and comprehensive benefits
- Health insurance options, retirement planning, and LifeWorks Global Employee Assistance Programme
- Flexible country-specific optional benefits (childcare vouchers, gym discounts, travel passes, health assessments, etc.)
- ICON is committed to inclusion and belonging with equal opportunity across all candidates