About this opportunity
Piper Companies lists this Central Monitor - 171901 opportunity in bethesda, Maryland. Review the employer’s description below for duties, qualifications and application requirements.
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
COVID-19 vaccination (first and second dose) required
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
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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Worksite address
bethesda, MD, 20811, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.