Clinical Research Monitor

Overview

Job Qualifications: Clinical Research, Data Compilation, Research Protocols

Job Description: Regular

Clearance Level Must Currently Possess:
None
Clearance Level Must Be Able To Obtain:
None

Public Trust/Other

Required:

NACLC (T3)

Job Family: Ancillary Health

Certifications: None

Experience: 4+ years of related experience

US Citizenship

Required:

Yes

GDIT's Military Health team is hiring a Clinical Research Monitor to support the Office of Regulated Activities (ORA) under the DoD (Dept. of Army) 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. ORA operates in a high-paced environment and seeks individuals who can work independently and take initiative in completing tasks.

The CRA 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.

This is a hybrid position and will report onsite 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 in order 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

• Bachelor’s degree, 4+ years of experience supporting clinical research
• Experience reviewing electronic source documents, electronic Case Report Forms (CRFs), and preparing Clinical Monitoring Reports and filing 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
• ORA operates in a high-paced environment and seeks individuals who can work independently and take initiative in completing tasks
• Must be a US Citizen with the ability to obtain a favorable NACLC T3 security investigation prior to start date

• Challenging work that makes a real impact on the world around you
• Internal mobility team dedicated to helping you own your career
• 401K with company match
• Diver…