Senior Clinical Research Associate

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

📋 Description

• Execute site management functions to ensure the success of the client's Oncology site and uphold continuous readiness for inspections.

• Serve as the primary liaison to facilitate communication between the client's clinical trial team and the sites.

• Conduct both remote and on-site monitoring/co-monitoring visits, which include Site Qualification, Site Initiation, Interim Monitoring, and Close-Out Visits.

• Oversee activities to 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 site documents and reconcile TMF with site files.

• Assist sites with local IRB/EC submissions and validate their approvals.

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

• Identify root causes and create or implement site CAPA plans.

• Provide training on protocols, SOPs, GCPs, and relevant regulations.

• Assist sites and the client's regulatory inspections.

• Participate in site identification, feasibility, qualification, and activation processes.

• Lead initiatives for site engagement and nurture relationships with 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 in monitoring solid tumor clinical trials.

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

• Required experience in solid tumor clinical trials.

• Proficiency with Veeva systems is highly desired.

• Proven ability to develop and maintain relationships with sites and ensure compliance.

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

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

• Familiarity with activating sites.

• Experience in training site personnel.

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

• Preferred experience working within 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 plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellness resources.

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