Senior Clinical Research Associate - Oncology

Job title: Senior Clinical Research Associate - Oncology

About the Role Senior Clinical Research Associate (Sr. CRA) will perform investigative site management and monitoring activities throughout the clinical trial lifecycle. This role supports the client's Oncology trials to ensure data integrity, subject safety, and inspection readiness at investigative sites.

What You'll Do

• Perform site management activities to support the client's Oncology site success and maintain a continuous state of inspection readiness
• Act as the primary contact and facilitate efficient communications between the client's clinical trial team and the sites
• Perform remote and on-site monitoring/co-monitoring visits (Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits and Close-Out Visits) to ensure data integrity and subject safety in the client's trials
• May perform oversight activities to assess monitoring quality and train/mentor less experienced CRAs
• Promptly document monitoring activities and submit/approve visit reports
• Manage site essential document collection and TMF reconciliation with site files
• Support sites with local Institutional Review Board (IRB)/Ethics Committee (EC) submissions and confirm approvals
• Regularly review site Key Risk Indicator (KRI) metrics, issues and action items to detect trends and ensure prompt resolution
• Independently determine root causes and develop/implement site Corrective Action and Preventive Action (CAPA) plans
• Deliver training to ensure sites comply with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) and regulations
• Support sites and the client's regulatory inspections
• Contribute to site identification; drive site feasibility and qualification progress; and support site activation activities
• Lead site engagement initiatives and foster relationships with key Oncology sites and networks

What We're Looking For

• Bachelor's degree (scientific field preferred)
• 5+ years monitoring clinical trials independently conducting on-site and remote monitoring visits
• At least 2 years monitoring solid tumor clinical trials and 1+ year of early development trial experience
• Solid tumor clinical trial experience required; experience with Veeva systems highly preferred
• Demonstrated experience developing/maintaining site relationships and ensuring 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 is preferred
• Willing to travel up to 75%

Nice to Have

• Experience utilizing Veeva systems is highly preferred

Compensation & Benefits

• Salary range: $110,520.00-$138,150.00 per year
• Benefits include various annual leave entitlements, health insurance offerings, competitive retirement planning, and a Global Employee Assistance Programme with 24-hour access to a global network
• Life assurance; flexible country-specific optional benefits (childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, and more)