Clinical Research Associate​/Clinical Research Monitor

As a Clinical Research Associate/Clinical Research Monitor you will help ensure today is safe and tomorrow is smarter. Our work depends on a Clinical Research Associate/Clinical Research Monitor joining our team to support the development of military-focused medical products. Seeking a Clinical Research Monitor to support the Office of Regulated Activities (ORA) under the DoW (Dept. of War) located rick in Frederick, Maryland.

The Office of Regulated Activities (ORA) is a multidisciplinary team of regulatory affairs, compliance, and clinical support professionals dedicated to supporting the USAMRDC mission of developing Food and Drug Administration regulated medical products for the Warfighter. The ORA provides full-service, oversight, and consultation for regulatory, clinical, non-clinical, manufacturing, data management, biostatistics, product technical, safety monitoring.

This is a hybrid position and will report onsite 1-2 days a week rick in Frederick, Maryland. Must reside within commuting distance.

• 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 to identify and mitigate safety and data quality risk issues, 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.

• Experience reviewing electronic source documents, electronic Case Report Forms (CRFs), preparing Clinical Monitoring Reports and filing them 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 annotating 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.

• Bachelor’s degree, 4+ years’ experience supporting clinical research.

• 5+ years of experience supporting clinical monitoring.

• Clinical trial monitoring, clinical trial monitoring plans, monitoring visits, site visit reports.

• NACI T1.

• Excellent written and verbal communication.

• Clinical trial monitoring support.
• Experience in a military research environment.

• Hybrid (Ft. Detrick, MD).

• ship.

• What is the mission of the program/contract? To support the development of military relevant medical products.
• What will a typical workday look like for the Contractor? Is this a team setting? Clinical monitors support the monitoring of active clinical trials by performing interim monitoring…