Central Monitor

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 useReview study protocols to confirm feasibility of KRIs and QTLs setup, reporting, and standardization requirementsLead risk assessments for studies and recommend protocol-specific risk indicators for centralized monitoringAssist with configuration and validation of centralized monitoring data analysis platformsAnalyze clinical study data to identify potential site performance or organizational issues and provide recommendations for CRA follow-upTrain project teams on interpreting central monitoring signals and making informed decisions for study conductMaintain and update operational risk logs for clinical risk management activitiesProvide guidance, mentorship, and coordination for all centralized monitoring tasksMonitor dashboards and outputs, suggest actions for signal management, and ensure timely resolution with study teamsAct as the SME for central monitoring during dashboard development and implementationAdvise clients and sponsors on best practices for centralized monitoring in a client-facing capacityCollaborate effectively with CRAs, Clinical Project Managers, Trial Managers, and Data Management teamsApply knowledge of regulatory requirements (FDA, ICH/GCP), data analysis, and statistical principles in central monitoring activitiesSupport government and commercial contracts across multiple therapeutic areas, including infectious disease, oncology, and medical devicesReport program status and potential risks to leadership and recommend mitigation strategiesEnsure adherence to documented processes and timelines, and take corrective action to prevent delaysMaintain accuracy and attention to detail in a fast-paced environment with shifting prioritiesComply with Quality Management System policies and proceduresContribute to corporate initiatives such as SOP development, process improvement, proposal writing, and bid defense meetingsAssist with audit preparation, inspection readiness, and post-inspection follow-up activitiesQualifications for the Central Monitor include:Strong understanding of ICH GCP and regulatory requirements, with emphasis on Risk-Based Quality Management and Central MonitoringMinimum of 3 years of experience in centralized monitoring within a CRO environmentPrevious experience as a CRA performing on-site monitoring or equivalent skill setFamiliarity with centralized monitoring database systems and processesProven ability to lead or mentor teams, develop procedures, and advise on best practices and tools for central monitoringExcellent facilitation, presentation, and problem-solving skills; strong written and verbal communication; attention to detail and quality control; and experience with clinical research systems and toolsBackground in infectious disease or oncology trials, or prior work on government contracts, is preferredBachelor's degree requiredCOVID-19 vaccination (first and second dose) requiredCompensation 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 LawThis job is open for applications on May 18th, 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#LI-MU1#LI-ONSITE