Clinical Research Monitor

Zachary 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. This is an opportunity for work that makes a real impact on the world around you. This is a hybrid position and will report onsite 2 days a week at Ft. Detrick in Frederick, MD . *Must reside in commuting distance*

Responsibilities of the Clinical Research Monitor:

• 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

Qualifications for the Clinical Research Monitor:

• 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.

Compensation for the Clinical Research Monitor:

• Salary Range: $70,000 - $85,000 *depending on experience*
• Comprehensive Benefits: Cigna Medical, Dental, Vision, 401k Plan, PTO, Holidays, Sick Leave if required by law

This job opens for applications on 2/2. Applications for this job will be accepted for at least 30 days from the posting date.

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