About this role
About the Role ICON is seeking a Senior Clinical Research Associate in Oncology based in Alberta, Canada. You will perform site management and monitoring to support Oncology trial site success, ensure data integrity and subject safety, and maintain inspection readiness. This role involves up to 75% travel to sites. What You'll Do
- Perform remote and on-site monitoring visits (Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits and Close-Out Visits) to ensure data integrity and subject safety in oncology trials.
- Act as the primary contact and facilitate efficient communications between the client's trial team and the sites.
- Document monitoring activities promptly and submit/approve visit reports; oversee monitoring quality and mentor less experienced CRAs.
- Manage site essential document collection and TMF reconciliation with site files.
- Support sites with local IRB/EC submissions and confirm approvals.
- Regularly review site Key Risk Indicators (KRIs), issues and action items to detect trends and drive prompt resolution; develop/implement CAPA plans.
- Drive site feasibility, identification and activation; contribute to site engagement and relationships with Oncology sites and networks.
- Support sites and sponsor in regulatory inspections.
- Ensure training of site staff on protocol, SOPs, GCPs, and regulations.
- Travel as required (up to 75%). What We're Looking For
- Bachelor’s degree (scientific field preferred).
- 5+ years of monitoring clinical trials with independent on-site and remote monitoring visits; at least 2 years monitoring solid tumor trials; 1+ year 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.
- Experience activating sites and training site staff.
- Experience supporting regulatory inspections.
- Experience working within a Functional Services (or in-house) monitoring model is preferred.
- Located in Alberta and willing to travel up to 75%. Nice to Have
- Additional oncology network relationships and site engagement experience is a plus.
- Prior experience with Veeva systems beyond basic usage. Compensation & Benefits
- Competitive salary with a range of benefits designed to support well-being and work-life balance.
- Health insurance options, retirement planning offerings, and LifeWorks Global Employee Assistance Programme (24/7 support).
- Life assurance and flexible country-specific optional benefits (childcare vouchers, gym discounts, travel passes, health assessments, etc.).