Responsibilities:

• Perform site management activities to support the client's Oncology site successandmaintainacontinuous state of inspection readiness

• Act as the primary contactandfacilitateefficientcommunications between the client's clinical trial team and the sites

• Perform remote and on-sitemonitoring/co-monitoringvisits (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 activitiesandsubmit/approvevisit 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,issuesandaction items to detect trends and ensure prompt resolution

• Independentlydeterminerootcauses and develop/implement site Corrective Action and Preventive Action (CAPA) plans

• Deliver training to ensure sitescomply withthe 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 activationactivities

• Lead site engagement initiatives and foster relationships with key Oncology sites and networks

Qualifications

• Bachelors degree (scientific field preferred)

• 5+yearsmonitoringclinicaltrials independently conducting on-site and remote monitoring visits. Atleast 2 years monitoring solid tumor clinical trials.

• 1+ years early development trialexperience

• Solidtumorclinicaltrial experience is required

• Experience utilizing Veeva systems is highly preferred

• Demonstrated experiencedeveloping/maintainingsiterelationships and securing compliance

• ExpertiseinGxPsandOncology monitoring techniques (including Risk-Based Monitoring) and terminology

• Experience collaborating with sitesfrominitialengagementthrough 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.

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.

Salary Range

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