Central Monitor - 171901

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 #J-18808-Ljbffr Piper Companies