Clinical Research Monitor (Remote)

Piper Companies is seeking a Clinical Research Monitor with expertise in risk-based quality management and centralized monitoring to ensure the integrity and compliance of clinical trials for a well-established CRO in the Bethesda, MD area. The Clinical Research Monitor role involves developing monitoring strategies, analyzing data trends, and guiding study teams to proactively identify and mitigate risks across multiple therapeutic areas.

Responsibilities of the Clinical Research Monitor:

·       Design and implement risk-based quality management frameworks, centralized monitoring processes, and supporting tools for clinical programs.

·       Review study protocols to confirm feasibility of Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) and ensure standardization across trials.

·       Lead protocol-specific risk assessments and recommend tailored risk indicators for centralized monitoring.

·       Support configuration and validation of centralized monitoring platforms and dashboards.

·       Analyze clinical data to detect site performance issues and organizational risks; provide actionable recommendations to CRAs and study teams.

·       Communicate effectively with cross-functional teams including CRAs, Clinical Project Managers, Data Management, and Analytics teams.

Qualifications of the Clinical Research Monitor:

·       3+ years of experience in centralized monitoring within a CRO or clinical research setting (required)

·       Prior experience as a CRA or equivalent monitoring role.

·       Experience working with infectious disease or oncology clinical research studies.

·       Strong knowledge of ICH-GCP, FDA regulations, and risk-based monitoring principles.

·       Familiarity with centralized monitoring technologies and data analysis tools.

·       eTMF, TMF, Veeva experience preferred

·       Bachelor’s degree in life sciences or related field; advanced degree preferred.

Compensation of the Clinical Research Monitor:

·       Salary Range: Between $85,000 - $110,000 based on years of relevant experience

·       Comprehensive Benefits: Medical, Dental, Vision, 401K, PTO, Paid Holidays, Sick Leave as required by law

This job opens for applications on 12/8/2025. Applications for this job will be accepted for at least 30 days from the posting date

Keywords:

Clinical Research Monitor, Centralized Monitoring, Risk-Based Quality Management, RBQM, Key Risk Indicators, KRI, Quality Tolerance Limits, QTLs, Risk Assessment, (RBQM), ICH-GCP, ICH, GCP, FDA Regulations, Good Clinical Practice, Clinical Trial Protocol Review, Regulatory Compliance, Audit Readiness, SOP Development, SOP, Standard Operating Procedure, Electronic Data Capture, EDC, Clinical Data Management Systems, CTMS, Central Monitoring Dashboards, Risk Management, Risk Log, Infectious Disease, Oncology, Vaccine, Medical Device, Clinical Research Organization, CRO, Government Contract, Federal Contract, Clinical Research Associate, CRA, Clinical Trial Associate, CTA, Clinical Trial Oversight, Proposal Writing, Budget Development, TMF, Trial Master File, eTMF, Veeva

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