Clinical Research Associate/Clinical Research Monitor

Job Title: Clinical Research Associate/Clinical Research Monitor
Location : Ft Detrick, Virginia
Type: Contract To Hire
Compensation : $70,000-90,000
Contractor Work Model: Hybrid (1-2days onsite)
Security Clearance: Must be a US Citizen with the ability to obtain a favorable NACI T1 security investigation prior to start date.

If interested reach out directly to [email protected] or call/text 301-252-8762

Job description:
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.

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.

How a Clinical Research Associate/Clinical Research Monitor will Make an Impact:
-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

What You’ll Need to Succeed:
-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.

Education:
Bachelors degree, 4+ year’s experience supporting clinical research

Required Experience:
5+ years of experience supporting clinical monitoring

Required Technical Skills:
Clinical trial Monitoring, Clinical Trial Monitoring Plans, Monitoring Visits, Site visit reports

Preferred Skills:
Clinical Trial Monitoring support
Experience in a military research environment

What are the top three skillsets the candidate should have? Experience supporting clinical trials, experience conducting site visits and generating site visit reports.

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Ref: #851-Rockville-S1

System One, and its subsidiaries including Joulé, ALTA IT Services, TeamPeople, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.