Oncology Research Professional

We are seeking an experienced clinical research associate to perform site management activities and support Oncology site success. The ideal candidate will have a strong background in monitoring, with experience conducting on-site and remote monitoring visits.

• Perform site qualification visits, site initiation visits, interim monitoring visits and close-out visits to ensure data integrity and subject safety in trials
• Act as the primary contact and facilitate efficient communications between the clinical trial team and the sites
• Conduct remote and on-site monitoring/co-monitoring visits to ensure data accuracy and compliance with regulatory requirements
• May conduct 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

• Bachelor's degree in a scientific field preferred
• 5+ years of experience in monitoring Oncology trials independently conducting on-site and remote monitoring visits
• 1+ years of early development trial experience
• Solid tumor clinical trial experience preferred
• Experience utilizing Veeva systems 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 preferred
• Willing to travel up to 50% domestically
• Reside in Midwest USA

• $110,520/year - $138,150/year

Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level.

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, we offer a range of additional benefits designed to be competitive within each country and focused on well-being and work life balance opportunities for you and your family.

Some examples include:

• Annual leave entitlements
• 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 offering 24-hour access to a global network of 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 with us.

We are dedicated to providing an inclusive and accessible environment for all candidates. We're 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, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We encourage you to apply regardless – there's every chance you're exactly what we're looking for here at our organisation.