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Central Monitor
Job
Piper Companies
Bethesda, MD (In Person)
$121,478 Salary, Full-Time
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Job Description
Piper Companies is looking for a Central Monitor to join a clinical research organization (CRO) company located in Bethesda, MD. Responsibilities of the Central Monitor include:
- 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
- Assist with configuration and validation of 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 for the Central Monitor include:
- 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