Overview
As a CRA you will be joining the world's largest and most comprehensive clinical research organisation, powered by healthcare intelligence.
What you will be doing
Perform site management activities to support Oncology site success and maintain a continuous state of inspection readiness
Act as the primary contact and facilitate efficient communications between the 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 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 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
You are:
Bachelor's degree (scientific field preferred)
2+ years monitoring Oncology trials independently conducting on-site and remote monitoring visits
At least 2 years of monitoring IP experience
Experience monitoring at USO IPC
Willing to perform PSSVs and SIVs as needed
Veeva RTSM (IRT) experience would be extremely helpful and highly preferred
Demonstrated experience developing/maintaining site relationships and securing compliance
Expertise in GCPs 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
Willing to travel up to 50% domestically (USO IPC in Dallas and other US depots)
Reside in Dallas, Texas or a major hub in Texas
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:
At ICON, inclusion and belonging are fundamental to our culture and values.
We're dedicated to providing an inclusive and accessible workplace for all candidates.
ICON is committed to providing a workplace free of discrimination and harassment.
All qualified applicants will receive equal consideration for employment without regard to race, color, 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 through the form below.
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.
#J-18808-Ljbffr
📌 Clinical Research Associate (Unblinded) - Oncology - Dallas, Texas
🏢 Icon
📍 Coffs Harbour