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 readiness for inspections.

• Serve as the main point of contact and facilitate 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 activities to evaluate monitoring quality and provide training or mentorship to less experienced CRAs.

• Record monitoring activities and submit or approve visit reports.

• Oversee the collection of essential site documents and ensure TMF reconciliation with site 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 develop or implement site CAPA plans.

• Provide training to ensure adherence to protocols, SOPs, GCPs, and regulations.

• Support sites during the client's regulatory inspections.

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

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

⛳️ Requirements

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

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

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

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

• Solid tumor clinical trial experience is mandatory.

• Proficiency with Veeva systems is highly desirable.

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

• Expertise in GxPs and Oncology monitoring methodologies, including Risk-Based Monitoring and related terminology.

• Experience working with sites from initial engagement through to the 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 within a Functional Services or in-house monitoring framework.

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

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

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, which may include medical, dental, and vision coverage.

• 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.