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About the role
Key responsibilities & impact- 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, including Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits and Close-Out Visits, to ensure data integrity and subject safety
- Perform oversight activities to assess monitoring quality and train/mentor less experienced CRAs
- Document monitoring activities and submit/approve visit reports
- Manage site essential document collection and TMF reconciliation with site files
- Support sites with local IRB/EC submissions and confirm approvals
- Review site KRI metrics, issues and action items to detect trends and ensure prompt resolution
- Determine root causes and develop/implement site CAPA plans
- Deliver training to ensure sites comply with protocols, SOPs, 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
Requirements
What you’ll need- 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
- 1+ years early development oncology trial experience and/or Phase I or Phase III Oncology trial experience
- 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
- 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 50%
- Employment with ICON is contingent upon having the legal right to work in the country where the role is based
Benefits
Comp & perks- 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