Central Monitor

Responsibilities

• Develop and maintain risk-based quality management and centralized monitoring processes, templates, and tools for corporate and trial-specific use
• Review study protocols to confirm feasibility of KRIs and QTLs setup, reporting, and standardization requirements
• Lead risk assessments for studies and recommend protocol-specific risk indicators for centralized monitoring
• Aid in configuring and validating centralized monitoring data analysis platforms
• Analyze clinical study data to identify potential site performance or organizational issues and provide recommendations for CRA follow-up
• Train project teams on interpreting central monitoring signals and making informed decisions for study conduct
• Maintain and update operational risk logs for clinical risk management activities
• Provide guidance, mentorship, and coordination for all centralized monitoring tasks
• Monitor dashboards and outputs, suggest actions for signal management, and ensure timely resolution with study teams
• Act as the SME for central monitoring during dashboard development and implementation
• Advise clients and sponsors on best practices for centralized monitoring in a client-facing capacity
• Collaborate effectively with CRAs, Clinical Project Managers, Trial Managers, and Data Management teams
• Apply knowledge of regulatory requirements (FDA, ICH/GCP), data analysis, and statistical principles in central monitoring activities
• Support government and commercial contracts across multiple therapeutic areas, including infectious disease, oncology, and medical devices
• Report program status and potential risks to leadership and recommend mitigation strategies
• Ensure adherence to documented processes and timelines, and take corrective action to prevent delays
• Maintain accuracy and attention to detail in a fast-paced environment with shifting priorities
• Comply with Quality Management System policies and procedures
• Contribute to corporate initiatives such as SOP development, process improvement, proposal writing, and bid defense meetings
• Assist with audit preparation, inspection readiness, and post-inspection follow-up activities

Qualifications

• Strong understanding of ICH GCP and regulatory requirements, with emphasis on Risk-Based Quality Management and Central Monitoring
• Minimum of 3 years of experience in centralized monitoring within a CRO environment
• Previous experience as a CRA performing on-site monitoring or equivalent skill set
• Familiarity with centralized monitoring database systems and processes
• Proven ability to lead or mentor teams, develop procedures, and advise on best practices and tools for central monitoring
• Excellent facilitation, presentation, and problem-solving skills; strong written and verbal communication; attention to detail and quality control; and experience with clinical research systems and tools
• Background in infectious disease or oncology trials, or prior work on government contracts, is preferred
• Bachelor’s degree required
• Covid-19 vaccination (first and second dose) required

Pay

Compensation for Central Monitor includes:

• Rate Range: $85,000-$125,000, depending on experience
• Comprehensive Benefit Package: Cigna Medical/Dental/Vision, 401K, Sick Leave as Required by Law

Benefits

This job is open for applications on July 7th, 2026. Applications will be accepted at least 30 days from the posting date.

Keywords: Central Monitoring, Risk-Based Quality Management, Clinical Trials, ICH GCP, KRIs, QTLs, Clinical Risk Management, CRO, CRA, Data Analysis, FDA Regulations, Oncology, Infectious Disease, Clinical Research, Remote, Bethesda MD

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