Senior Clinical Research Associate

ICON plc • Miami, FL

7d

About The Position

The Senior Clinical Research Associate will work in a sponsor-dedicated model at ICON Strategic Solutions, supporting oncology clinical trial sites in Miami/South Florida. The role focuses on site management, monitoring, data integrity, subject safety, inspection readiness, and effective communication between the client’s clinical trial team and sites. The position may also include monitoring oversight and mentoring less experienced CRAs, as well as leading site engagement and supporting sites from feasibility and activation through close-out.

Requirements

• Bachelor’s degree; a scientific field is preferred.
• At least 5 years of experience independently monitoring clinical trials through on-site and remote visits.
• At least 2 years of experience monitoring solid tumor clinical trials.
• Solid tumor clinical trial experience.
• At least 1 year of early-development oncology trial experience and/or Phase III oncology trial experience.
• Demonstrated experience developing and maintaining site relationships and securing compliance.
• Expertise in GxPs, oncology monitoring techniques (including Risk-Based Monitoring), and related terminology.
• Experience collaborating with sites from initial engagement through close-out.
• Experience activating sites.
• Experience training site staff.
• Experience supporting sites and/or sponsors during regulatory inspections.
• Willingness to travel up to 50%.

Nice To Haves

• Experience using Veeva systems.
• Experience working within a Functional Services or in-house monitoring model.

Responsibilities

• Perform site management activities to support oncology site success and maintain inspection readiness.
• Serve as the primary contact and facilitate communication between the client’s clinical trial team and sites.
• Conduct remote and on-site monitoring or co-monitoring visits, including Site Qualification, Site Initiation, Interim Monitoring, and Close-Out visits, to ensure data integrity and subject safety.
• Perform oversight activities to assess monitoring quality and train or mentor less experienced CRAs, as needed.
• Document monitoring activities promptly and submit or approve visit reports.
• Manage collection of essential site documents and reconcile the TMF with site files.
• Support sites with local IRB/Ethics Committee submissions and confirm approvals.
• Review site KRI metrics, issues, and action items to identify trends and ensure timely resolution.
• Determine root causes and develop and implement site CAPA plans independently.
• Train sites to ensure compliance with the protocol, SOPs, GCPs, and regulations.
• Support sites and the client during regulatory inspections.
• Contribute to site identification, drive site feasibility and qualification, and support site activation.
• Lead site engagement initiatives and foster relationships with key oncology sites and networks.

Benefits

• Competitive base salary and performance-related incentives.
• Health and wellbeing programmes, including medical, dental, and vision coverage where applicable.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programmes and wellbeing resources.
• Learning and development opportunities through structured training and career pathways.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior