Senior Clinical Research Associate

This is a fully remote position, open to applicants in Texas.

📋 Description

• Carry out site management tasks to ensure the success of the client's Oncology site and uphold a constant state of inspection readiness.

• Serve as the main point of contact and facilitate effective communication between the client's clinical trial team and the sites.

• Conduct both remote and on-site monitoring/co-monitoring visits, including Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits, to guarantee data integrity and ensure subject safety.

• Oversee activities to evaluate monitoring quality and provide training/mentorship to less experienced CRAs.

• Record monitoring activities and prepare/approve visit reports.

• Manage the collection of essential site documents and ensure TMF reconciliation with site files.

• Assist sites with local IRB/EC submissions and confirm the receipt of approvals.

• Analyze site KRI metrics, issues, and action items to identify trends and ensure timely resolution.

• Identify root causes and develop/implement site CAPA plans.

• Provide training to ensure that sites adhere to protocols, SOPs, GCPs, and regulations.

• Support sites during the client's regulatory inspections.

• Contribute to site identification, drive the progress of site feasibility and qualification, and assist in site activation activities.

• Lead initiatives for site engagement and cultivate relationships with key Oncology sites and networks.

⛳️ Requirements

• Bachelor's degree (preferably in a scientific field).

• Over 5 years of experience in monitoring clinical trials independently, conducting both on-site and remote monitoring visits.

• A minimum of 2 years of experience monitoring solid tumor clinical trials.

• At least 1 year of experience in early development oncology trials and/or Phase I or Phase III Oncology trials.

• Solid tumor clinical trial experience is essential.

• Experience with Veeva systems is highly preferred.

• Proven experience in developing and maintaining site relationships and ensuring compliance.

• Expertise in GxPs and Oncology monitoring techniques (including Risk-Based Monitoring) as well as relevant terminology.

• Experience collaborating with sites from initial engagement through to close-out phases.

• Experience in activating sites.

• Experience in training site staff.

• Experience assisting sites and/or sponsors during regulatory inspections.

• Preference for experience working within a Functional Services (or in-house) monitoring model.

• Willingness to travel up to 50%.

• Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellbeing programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellbeing resources.

• Opportunities for learning and development through structured training and career pathways.