Responsibilities:

• 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  

Qualifications

• Bachelor’s degree (scientific field preferred) 
• 5+ years monitoring clinical trials independently conducting on-site and remote monitoring visits. Atleast 2 years monitoring solid tumor clinical trials.
• 1+ years early development 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 
• Located in Alberta and willing to travel up to 75% 

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• 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

Benefits may vary depending on role and location.

Visit our to read more about the benefits ICON offers.

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