Senior Clinical Research Associate

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

📋 Description

• Oversee site management functions for the client's Oncology clinical trials while ensuring inspection readiness.

• Serve as the main liaison between the client's clinical trial team and investigative sites.

• Conduct both remote and on-site monitoring/co-monitoring visits across the entire clinical trial lifecycle.

• Evaluate monitoring quality and provide training or mentorship to less experienced CRAs.

• Record monitoring activities and either submit or approve visit reports.

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

• Assist with local IRB/Ethics Committee submissions and verify approvals.

• Analyze site Key Risk Indicator metrics, issues, and action items.

• Identify root causes and formulate or execute site CAPA plans.

• Train sites on protocols, SOPs, GCPs, and relevant regulations.

• Support regulatory inspections.

• Aid in site identification, feasibility assessments, qualification, and activation.

• Lead initiatives to engage sites and cultivate relationships with Oncology sites and networks.

⛳️ Requirements

• Bachelor’s degree, preferably in a scientific field.

• Over 5 years of experience in monitoring clinical trials, including independent on-site and remote monitoring visits.

• At least 2 years of experience monitoring solid tumor clinical trials.

• More than 1 year of experience in early development trials.

• Required experience in solid tumor clinical trials.

• Highly preferred experience with Veeva systems.

• Proven track record in developing and maintaining site relationships while ensuring compliance.

• In-depth knowledge of GxPs and Oncology monitoring methodologies, including Risk-Based Monitoring and terminology.

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

• Familiarity with site activation processes.

• Experience in training site personnel.

• Background in supporting sites and/or sponsors during regulatory inspections.

• Preferred experience in a Functional Services or in-house monitoring model.

• Willingness to travel up to 50% of the time.

• Legal authorization to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

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

• Retirement and pension schemes.

• Life assurance and disability coverage.

• Employee assistance programs and wellness resources.

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

• Reasonable accommodations provided during the recruitment process.

• An inclusive and accessible workplace.