Senior Clinical Research Associate

ICON plc; Miami (FL); Sur place; USD 90 000 - 120 000; Plein temps

Avantages offerts par ce poste

Annual leave

Health insurance

Retirement planning

Employee Assistance Program (LifeWorks

Life assurance

Flexible country-specific benefits

Résumé du poste

ICON Strategic Solutions in Miami/South Florida seeks a Senior Clinical Research Associate with oncology expertise to support sponsor trials. You will monitor sites, ensure data integrity and patient safety across remote and on-site visits, and collaborate with site teams to drive trial success.

Responsibilities include QA oversight, training, CAPA development, IRB submissions, and supporting regulatory inspections. Expect travel up to 50% as needed.

Qualifications

• Bachelor’s degree in a scientific field is preferred.
• 5+ years monitoring clinical trials with on-site and remote visits.
• 1+ years in oncology trials (solid tumors) recommended.
• Experience with regulatory inspections and site staff training.
• Experience in Veeva systems is highly preferred.

Responsabilités

• Perform site management activities and ensure inspection readiness.
• Serve as main liaison between the client’s clinical trial team and sites.
• Conduct remote and on-site monitoring visits to ensure data integrity and patient safety.
• Provide oversight to assess monitoring quality, train staff, and mentor junior CRAs.
• Document monitoring activities and submit visit reports promptly.
• Manage site essential documents and TMF reconciliation.
• Support IRB/EC submissions and approvals.

Connaissances

Monitoring clinical trials

On-site monitoring

Remote monitoring

GxP and Oncology monitoring

Risk-Based Monitoring

Veeva systems

Site management

CAPA

Formation

Bachelor’s degree (scientific field preferred)

Outils

Veeva systems

Description du poste

Senior Clinical Research Associate - Oncology - Miami/South Florida

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

Responsibilities:

• Perform site management activities to support the client's Oncology site successandmaintainacontinuous state of inspection readiness
• Act as the primary contactandfacilitateefficientcommunications between the client's clinical trial team and the sites
• Perform remote and on-sitemonitoring/co-monitoringvisits (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/approvevisit 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 oncology trialexperienceand/or Phase III Oncology trial experience
• 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.

Visit our careers site to read more about the benefits ICON offers.

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