Senior Clinical Research Associate

Senior Clinical Research Associate - Oncology - New York ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. 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  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 careers site to read more about the benefits ICON offers. Inclusion and Accessibility ICON 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. Salary Range $110,520.00-$138,150.00 Are you a current ICON Employee? Please click here to apply