Senior CRA (Remote - Central Texas)

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

As a Sr CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

The Sr. Clinical Research Associate (Sr. CRA) will be responsible for performing investigative site management and monitoring activities throughout the clinical trial lifecycle. This Sr. CRA role will support Eikon Oncology clinical trials to ensure data integrity, subject safety, and inspection readiness at the clinical investigative sites in the United States (US).

• Responsibilities:

  • Perform site management activities to support Eikon Oncology site success and maintain a continuous state of inspection readiness
  • Act as the primary contact and facilitate efficient communications between the Eikon 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 Eikon 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 Eikon during 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 Oncology trials independently conducting on-site and remote monitoring visits
• 1+ years early development trial experience
• Solid tumor clinical trial experience is preferred
• Experience utilizing Veeva systems is 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 an FSP (or in-house) monitoring model is preferred

What ICON can offer you:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.