5+ years of independent clinical trial monitoring experience, including 2 years in solid tumor trials
1+ years of experience in early development or Phase III oncology trials
Solid tumor clinical trial experience required
Experience with Veeva systems preferred
Strong relationship-building skills with sites
Expertise in GxPs and oncology monitoring techniques, including Risk-Based Monitoring
Responsibilities
Perform site management activities to ensure continuous inspection readiness
Act as primary contact for communication between clinical trial teams and sites
Conduct remote and on-site monitoring visits to ensure data integrity and subject safety
Oversee monitoring quality and mentor less experienced CRAs
Document monitoring activities and manage site essential documents
Support sites with IRB/Ethics Committee submissions and approvals
Review site Key Risk Indicator metrics to detect trends and resolve issues
Develop and implement site Corrective Action and Preventive Action plans
Deliver training to ensure compliance with protocols and regulations
Lead site engagement initiatives and foster relationships with key oncology sites
Benefits
Various annual leave entitlements
Comprehensive health insurance options for you and your family
Competitive retirement planning offerings
Global Employee Assistance Programme for family well-being support
Life assurance
Flexible optional benefits including childcare vouchers and discounted gym memberships
Full Job Description
Senior Clinical Research Associate - Oncology - Southeast/Florida
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 oncology trial experience and/or Phase III Oncology 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%
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 maximize savings and plan with confidence for the years ahead.
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
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.
Are you a current ICON Employee? Please click here to apply
About ICON plc
ICON plc is a global provider of drug development and commercialisation services to the pharmaceutical, biotechnology and medical device industries. The company specialises in the strategic development, management and analysis of programs that support clinical development. ICON has approximately 15700 employees in 40 countries. The company was founded in Dublin, Ireland in 1990 and is headquartered in Leopardstown, Dublin. ICON has been publicly traded on the NASDAQ since 1998.
