Senior Clinical Research Associate

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

📋 Description

• Execute site management tasks to facilitate the success of the client's Oncology site and ensure ongoing inspection readiness.

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

• Conduct both remote and on-site monitoring/co-monitoring visits, including 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 them with TMF files.

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

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

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

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

• Support sites during the client's regulatory inspections.

• Contribute to activities related to site identification, feasibility, qualification, and activation.

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

⛳️ Requirements

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

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

• 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 III Oncology trials.

• Required experience in solid tumor clinical trials.

• Proficiency in using Veeva systems is highly preferred.

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

• Knowledgeable in GxPs and Oncology monitoring techniques, including Risk-Based Monitoring and relevant terminology.

• Experience working with sites from initial engagement through to the 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 model or in-house monitoring.

• Willingness to travel up to 50%.

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

🏝️ 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 insurance and disability coverage.

• Employee assistance programs and wellness resources.

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