As a Senior CRA  you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.  In this role you will be responsible for performing investigative site management and monitoring activities throughout the clinical trial lifecycle of Phase I and Phase III Oncology studies.  You will also ensure data integrity, subject safety and inspection readiness at sites.

In this role you will:

• 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
• 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 wil need:

• 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

. Phase I experience is mandatory
• 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 and training site staff
• Fluent Danish language skills
• Experience supporting sites and/or sponsors in regulatory inspections
• 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 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

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment 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.

https://careers.iconplc.com/reasonable-accommodations

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.