Senior Clinical Research Associate

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

📋 Description

• Conduct site management and monitoring tasks throughout the entirety of the clinical trial lifecycle.

• Assist in the client's Oncology clinical trials to guarantee data integrity, subject safety, and readiness for inspections.

• Execute site management responsibilities while ensuring ongoing inspection preparedness.

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

• Carry out remote and on-site monitoring/co-monitoring visits, which include qualification, initiation, interim monitoring, and close-out visits.

• Oversee activities to evaluate monitoring quality and provide training or mentorship to less experienced Clinical Research Associates (CRAs).

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

• Manage the collection of essential site documents and reconcile the Trial Master File (TMF) with site files.

• Assist with local Institutional Review Board (IRB)/Ethics Committee submissions and verify approvals.

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

• Identify root causes and create or implement site Corrective and Preventive Action (CAPA) plans.

• Provide training on protocols, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and regulations.

• Support sites and the client during regulatory inspections.

• Play a role in site identification, feasibility assessments, qualification, and activation activities.

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

⛳️ Requirements

• Bachelor's degree in a relevant scientific field is preferred.

• A minimum of 5 years of experience in monitoring clinical trials and independently conducting both 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 oncology trials and/or Phase III Oncology trial experience.

• Essential experience in solid tumor clinical trials is required.

• Proficiency with Veeva systems is highly preferred.

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

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

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

• Experience in activating sites.

• Experience in training site personnel.

• Familiarity with supporting sites and/or sponsors during regulatory inspections.

• Experience working within a Functional Services model or an in-house monitoring framework is preferred.

• 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.

• Performance-based incentives.

• 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.