Zachary Piper Solutions · 12 hours ago
Clinical Research Monitor
Frederick, MD
Full-time
Hybrid
Mid Level
$70K/yr - $85K/yr
4+ years expZachary Piper Solutions is seeking a Clinical Research Monitor to join a leading federal health IT solutions provider located in Frederick, MD for a hybrid role. The Clinical Research Monitor will provide clinical trial monitoring to ensure all sponsor required trial monitoring is conducted and all deliverables are provided according to 21 CFR 312 and ICH guidelines.
GovernmentInformation ServicesInformation TechnologySoftware
No H1B
Security Clearance RequiredU.S. Citizen Only
Responsibilities
Develop a Clinical Monitoring Plan and monitor single site and multicenter clinical studies both inside and outside the continental United States; when required, conduct centralized monitoring activities
Remote review of electronic source documents, electronic Case Report Forms (CRFs), trends, and metrics in order to identify and mitigate safety and data quality risk issue(s), prepare Clinical Monitoring Reports and file in the sponsor’s regulatory file. The monitoring reports shall include the date of activities, description of the activities, and any findings from the activities-Prepare protocol deviations and violation and non-compliance reports
Provide remote evaluation of the study data, carried out by a team including central monitors, medical reviewers at a location other than the sites at which the clinical investigation is being conducted and annotate in monitoring reports for the sponsor’s regulatory file
Prepare/review calibration and maintenance records, which are records kept at the clinical site that document the calibration and maintenance of all applicable equipment utilized during the execution of the clinical trial including laboratory equipment, and ensure equipment is adequate, current, accessible and annotate this information in monitoring reports for the sponsor’s regulatory file
Prepare and/or review shipment records, which include shipping documentation for investigation products, biological samples, and if applicable, other study supplies provided to the clinical sites
Prepare and/or review laboratory sample analysis reports
Qualification
Required
Bachelors degree w/ 4+ year's experience supporting clinical research
Experience reviewing electronic source documents, electronic Case Report Forms (CRFs), prepare Clinical Monitoring Reports and file in the sponsor's regulatory file
Experience providing remote evaluation of the study data
Experience preparing/reviewing calibration and maintenance records to ensure equipment is adequate, current, accessible and annotate this information in monitoring reports for the sponsor's regulatory file
Experience preparing and/or reviewing shipment records, documentation for investigation products, biological samples, and other study supplies provided to the clinical sites
Must be a US Citizen with the ability to obtain a favorable NACLC T3 security investigation prior to start date
Benefits
Cigna Medical
Dental
Vision
401k Plan
PTO
Holidays
Sick Leave if required by law
Company
Zachary Piper Solutions
Zachary Piper Solutions is an IT company providing government contracting solutions in support of the nation’s Intelligence Community.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
$3M2018-02-22Series Unknown· $1.3M
2014-04-10Series Unknown· $1.7M
Leadership Team
Christopher Stroud
Partner Outreach & Engagements
Justin Jordan
Founder and Chairman
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