Senior Clinical Research Associate

Senior Clinical Research Associate - Oncology - Miami/South FloridaAt ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON's global expertise. As the world's largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.Responsibilities:Perform site management activities to support the client's Oncology site success and maintain a continuous state of inspection readinessAct as the primary contact and facilitate efficient communications between the client's clinical trial team and the sitesPerform 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 trialsMay perform oversight activities to assess monitoring quality and train/mentor less experienced CRAsPromptly document monitoring activities and submit/approve visit reportsManage site essential document collection and TMF reconciliation with site filesSupport sites with local Institutional Review Board (IRB)/Ethics Committee (EC) submissions and confirm approvalsRegularly review site Key Risk Indicator (KRI) metrics, issues and action items to detect trends and ensure prompt resolutionIndependently determine root causes and develop/implement site Corrective Action and Preventive Action (CAPA) plansDeliver training to ensure sites comply with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) and regulationsSupport sites and the client's regulatory inspectionsContribute to site identification; drive site feasibility and qualification progress; and support site activation activitiesLead site engagement initiatives and foster relationships with key Oncology sites and networksQualificationsBachelor'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 III Oncology trial experienceSolid tumor clinical trial experience is requiredExperience utilizing Veeva systems is highly preferredDemonstrated experience developing/maintaining site relationships and securing complianceExpertise in GxPs and Oncology monitoring techniques (including Risk-Based Monitoring) and terminologyExperience collaborating with sites from initial engagement through close-out phasesExperience activating sitesExperience training site staffExperience supporting sites and/or sponsors in regulatory inspectionsExperience working within a Functional Services (or in-house) monitoring model is preferredWilling 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 & BenefitsICON 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 incentivesHealth and wellbeing programmes including medical, dental, and vision coverage where applicableRetirement and pension plansLife assurance and disability coverageEmployee assistance programmes and wellbeing resourcesLearning and development opportunities through structured training and career pathwaysBenefits may vary depending on role and location.Inclusion and AccessibilityICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.