Senior Clinical Research Associate

This is a fully remote position, open to applicants in Alabama, +8 more states.

📋 Description

• Oversee site management activities to ensure the client's Oncology site achieves success and remains ready for inspections.

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

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

• Perform oversight activities to evaluate monitoring quality and provide training/mentorship to less experienced CRAs.

• Record monitoring activities and manage the submission and approval of visit reports.

• Oversee the collection of essential site documents and ensure TMF reconciliation.

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

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

• Investigate root causes and create/execute site CAPA plans.

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

• Aid sites and support the client's regulatory inspections.

• Contribute to site identification, feasibility assessments, qualification, and activation processes.

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

⛳️ Requirements

• Bachelor’s degree, preferably in a scientific discipline.

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

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

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

• Required experience in solid tumor clinical trials.

• Highly preferred experience with Veeva systems.

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

• Proficient knowledge in GxPs and Oncology monitoring methodologies, including Risk-Based Monitoring and relevant terminology.

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

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

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

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellbeing resources.

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