Senior Clinical Research Associate

ICON; Chicago (IL); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Annual leave

Health insurance

Retirement planning

Employee Assistance Programme

Life insurance

Flexible benefits

Job summary

ICON plc in Chicago seeks a Senior Clinical Research Associate for Oncology Phase I to manage investigative sites and monitor trials, ensuring data integrity and subject safety. You will perform site qualification visits, maintain inspection readiness, and collaborate with trial teams.

Travel up to 50% and mentoring junior CRAs are included; regulatory inspections support. The role requires a Bachelor's in a scientific field, 5+ years monitoring experience, and oncology trials exposure.

Qualifications

• Bachelor’s degree in a scientific field is required or preferred.
• 5+ years of monitoring clinical trials independently (on-site and remote).
• At least 2 years monitoring solid tumor trials.
• 1+ year in early development trial experience.
• Solid tumor oncology experience required.
• Experience with GxP and oncology monitoring techniques.
• Experience collaborating with sites through FDA/IRB inspections.
• Willing to travel up to 50%.

Responsibilities

• Perform on-site and remote site management and monitoring activities throughout trials.
• Serve as primary contact and enable effective communication between trial team and sites.
• Conduct site qualification/initiation, interim monitoring, and close-out visits to ensure data integrity and subject safety.
• Provide oversight to monitor quality; train/mentor junior CRAs.
• Document monitoring activities and submit visit reports promptly.
• Manage site essential documents and TMF reconciliation.
• Support IRB/EC submissions and ensure approvals.
• Review KRIs and action items to detect trends and drive CAPA.
• Lead site engagement and activation activities and foster oncology site networks.
• Support regulatory inspections and feasibility assessments.

Skills

GxP knowledge

Oncology monitoring

Clinical trial monitoring

Site management

Regulatory inspections experience

Education

Bachelor’s degree (scientific field preferred)

Tools

Veeva systems

Job description

Senior Clinical Research Associate - Oncology Phase I - Chicago

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.

The Sr. Clinical Research Associate (Sr. CRA) willbe responsible forperforming investigative site management and monitoring activities throughout the clinical trial lifecycle. This Sr. CRA role will support the client's Oncology clinical trials to ensure data integrity, subject safety, andinspectionreadiness at the clinical investigative sites.

Responsibilities

• Perform site management activities to support the client's Oncology site successandmaintaina continuous state of inspection readiness
• Act as the primary contactandfacilitateefficient communications between the client's clinical trial team and the sites
• Perform remote and on-sitemonitoring/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 activitiesandsubmit/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,issuesandaction items to detect trends and ensure prompt resolution
• Independentlydeterminerootcauses and develop/implement site Corrective Action and Preventive Action (CAPA) plans
• Deliver training to ensure sitescomply withthe 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 activationactivities
• Lead site engagement initiatives and foster relationships with key Oncology sites and networks

Qualifications

• Bachelor’s degree (scientific field preferred)
• 5+yearsmonitoringclinicaltrials independently conducting on-site and remote monitoring visits. Atleast 2 years monitoring solid tumor clinical trials.
• 1+ years early development trialexperience
• Solidtumorclinicaltrial experience is required
• Experience utilizing Veeva systems is highly preferred
• Demonstrated experiencedeveloping/maintainingsiterelationships and securing compliance
• ExpertiseinGxPsandOncology monitoring techniques (including Risk-Based Monitoring) and terminology
• Experience collaborating with sitesfrominitialengagementthrough 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.

At ICON, inclusion & belonging are fundamental to our culture and values. 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 or submit a request here