Clinical Research Monitor

Piper Companies is looking for a Clinical Research Monitor to join a federal government-supported organization located in Frederick, Maryland.

Responsibilities of the Clinical Research Monitor include:

· Develop Clinical Monitoring Plans and oversee single-site and multi-center clinical studies in the U.S. and internationally, including centralized monitoring when needed

· Conduct remote review of electronic source documents, eCRFs, trends, and metrics to identify and address safety or data-quality risks; prepare Clinical Monitoring Reports and file them in the sponsor's regulatory records

· Document protocol deviations, violations, and non-compliance reports

· Provide remote evaluation of study data in collaboration with central monitors and medical reviewers, and document results in monitoring reports

· Review calibration and maintenance records to confirm equipment used in clinical trials is current, adequate, and accessible, and record findings in monitoring reports

· Prepare and/or review shipment records for investigational products, biological samples, and other study supplies

· Prepare and/or review laboratory sample analysis reports

Qualifications for the Clinical Research Monitor include:

· Bachelor's degree and 4+ years of clinical research experience

· Experience reviewing electronic source documents, eCRFs, and preparing Clinical Monitoring Reports for regulatory files

· Experience performing remote study data evaluation

· Experience reviewing calibration and maintenance records to verify equipment adequacy and compliance

· Experience preparing or reviewing shipment documentation for investigational products, biological samples, and study supplies

Compensation for the Clinical Research Monitor includes:

· Rate Range: $40/hr

· Comprehensive Benefit Package: Cigna Medical/Dental/Vision, 401K, Sick Leave as Required by Law

This job is open for applications on February 2nd, 2026. Applications will be accepted for at least 30 days from the posting date.

Keywords: Clinical Research Monitor, clinical trial monitoring, centralized monitoring, remote monitoring, clinical data review, eCRFs, electronic source documents, Clinical Monitoring Plan, Clinical Monitoring Reports, protocol deviation reporting, non-compliance reporting, ICH guidelines, ICH-GCP, 21 CFR 312 compliance, FDA-regulated studies, regulatory documentation, sponsor regulatory file, QA/QC review, data integrity, data quality metrics, safety risk assessment, ORA support, shipment record review, biological sample handling, lab sample analysis reports, calibration records review, equipment qualification, multicenter studies, site compliance oversight, clinical study documentation, monitoring visit reports, trending analysis, audit readiness, clinical operations, regulatory affairs support, risk-based monitoring, remote data evaluation, source data verification, SOP adherence, clinical site management, FDA medical product development, study file maintenance

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