Senior Clinical Research Associate

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

📋 Description

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

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

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

• Oversee 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 documents from the site and reconcile the Trial Master File (TMF) with site records.

• Assist sites with submissions to local Institutional Review Boards/Ethics Committees and confirm approvals.

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

• Identify root causes and create or implement Corrective Action and Preventive Action plans for sites.

• Provide training to ensure compliance with protocol, Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and regulatory standards.

• Support both the sites and the client during regulatory inspections.

• Participate in site identification, drive feasibility and qualification progress, and assist in site activation efforts.

• Lead initiatives to engage sites and build 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.

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

• A minimum of 1 year of experience in early development oncology trials and/or Phase I or Phase III Oncology trial experience.

• Required experience in solid tumor clinical trials.

• Proficiency in using Veeva systems is highly desirable.

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

• Expertise in Good Practice (GxP) regulations and Oncology monitoring techniques, including Risk-Based Monitoring and relevant terminology.

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

• Familiarity with site activation processes.

• Experience in training site personnel.

• Experience 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 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 advancement pathways.