Senior Clinical Research Associate

IRE • Miami, FL

5d

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 contributes to site success, inspection readiness, data integrity, and subject safety, while supporting the development of treatments for patients worldwide.

The position manages site relationships and trial activities from initial engagement through close-out. It includes remote and on-site monitoring, site activation and feasibility support, document and TMF reconciliation, risk review, corrective and preventive action planning, staff training, and support for regulatory inspections. The role may also include monitoring oversight and mentoring less experienced CRAs. Travel of up to 50% is required.

Requirements

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

Nice To Haves

• Experience using Veeva systems is highly preferred.
• Experience working in a Functional Services or in-house monitoring model is preferred.
• A bachelor's degree in a scientific field is preferred.

Responsibilities

• Perform site management activities to support oncology site success and maintain inspection readiness.
• Serve as the primary contact between the client's clinical trial team and sites, facilitating efficient communication.
• Conduct remote and on-site monitoring or co-monitoring visits, including Site Qualification, Site Initiation, Interim Monitoring, and Close-Out Visits.
• 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 Trial Master File with site files.
• Support sites with local Institutional Review Board (IRB) or Ethics Committee (EC) submissions and confirm approvals.
• Review site Key Risk Indicator (KRI) metrics, issues, and action items to identify trends and ensure timely resolution.
• Determine root causes and develop and implement site Corrective Action and Preventive Action (CAPA) plans independently.
• Train sites to ensure compliance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and regulations.
• Support sites and the client during regulatory inspections.
• Contribute to site identification, drive site feasibility and qualification progress, and support site activation.
• Lead site engagement initiatives and build relationships with key oncology sites and networks.

Benefits

• Competitive base salary and performance-related incentives.
• 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.
• Health and wellbeing programmes.

What This Job Offers

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