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General Dynamics Information Technology · 7 hours ago

Clinical Research Monitor

Frederick, MD

Full-time

Hybrid

Mid Level

$60K/yr - $80K/yr

4+ years exp

General Dynamics Information Technology is seeking a Clinical Research Monitor to support the Office of Regulated Activities under the DoD located at Ft. Detrick in Frederick, Maryland. The role involves developing clinical monitoring plans, conducting remote evaluations of study data, and ensuring compliance with regulatory requirements.

Artificial Intelligence (AI)Cloud ComputingConsultingCyber SecurityInformation Technology

No H1B

Security Clearance Required

U.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

Clinical ResearchData CompilationResearch ProtocolsElectronic Source DocumentsClinical Monitoring Reports

Required

Bachelors degree

4+ years of related experience supporting clinical research

Experience reviewing electronic source documents

Experience reviewing electronic Case Report Forms (CRFs)

Experience 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

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

401K with company match

Variety of medical plan options, some with Health Savings Accounts

Dental plan options

Vision plan

Full flex work weeks

Variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave

Short and long-term disability benefits

Life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance

Company

General Dynamics Information Technology

Glassdoor3.9

General Dynamics Information Technology is an IT consulting company that specializes in cyber security, AI, and quantum computing. It is a sub-organization of General Dynamics.

Founded in 1999

Falls Church, Virginia, USA

10001+ employees