Senior Clinical Research Associate

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

📋 Description

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

• Serve as the primary liaison to facilitate effective communication between the client's clinical trial team and the sites.

• Conduct both remote and on-site monitoring/co-monitoring visits (Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits) to guarantee data integrity and subject safety in the client's trials.

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

• Timely document monitoring activities and prepare/approve visit reports.

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

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

• Regularly analyze site Key Risk Indicator (KRI) metrics, issues, and action items to identify trends and ensure timely resolution.

• Independently identify root causes and create/implement site Corrective Action and Preventive Action (CAPA) plans.

• Provide training to ensure sites adhere to the protocol, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and relevant regulations.

• Support sites during the client's regulatory inspections.

• Contribute to site identification; facilitate site feasibility and qualification progress; and assist in site activation activities.

• Lead initiatives to engage sites and cultivate 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 monitoring solid tumor clinical trials.

• More than 1 year of experience in early development trial settings.

• Required experience in solid tumor clinical trials.

• Familiarity with Veeva systems is highly preferred.

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

• Proficient in GxPs and Oncology monitoring techniques (including Risk-Based Monitoring) and related terminology.

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

• Experience in site activation.

• Experience in training site staff.

• 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 75%.

🏝️ 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.