Clinical Research Monitor

Clearance Level
None
Category
Medical Affairs
Location
Fort Detrick, Maryland
(Hybrid Workplace)
Apply Now
Key Skills For Success

Clinical Research

Data Compilation

Research Protocols

REQ#: RQ201473
Public Trust: NACLC (T3)
Requisition Type: Pipeline
Your Impact

Own your opportunity to work alongside federal civilian agencies. Make an impact by providing services that help the government ensure the well being of U.S. citizens.

Job Description
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 at Ft. Detrick 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 at Ft. Detrick in Frederick, Maryland. Must reside within commuting distance.The CRA shall provide clinical trial monitoring to ensure clinical trials are conducted and deliverables provided according to 21 CFR 312, International Conference on Harmonization (ICH) practices, other applicable regulations, policies, and ORA SOPs.  The monitor will:HOW YOU WILL MAKE AN IMPACT:
  • Develop, implement, and maintain clinical monitoring plans.
  • Perform onsite and/or remote clinical monitoring activities inside and outside the continental United States for site qualification, site initiation, interim, and close-out visits.
  • Qualify sites for conducting clinical trials, which includes developing criteria, conducting the visit, documenting the findings, and making recommendations on whether a proposed clinical site and principal investigator (PI) meet the requirements for executing of the proposed clinical trial
  • Prepare or review calibration and maintenance records to ensure equipment is adequate, current, and accessible.
  • Review and help maintain clinical site regulatory files, also referred to as the regulatory binder or site file.
  • Prepare and perform site initiation training
  • Review electronic and/or paper source documents for completion, accuracy, and consistency
  • Perform source data verification (SDV) to ensure the quality and accuracy of data recorded and in a timely manner to allow major study milestones to occur on schedule. 
  • Generate and resolve queries to address any findings, issues, and/or inconsistencies in a timely manner to allow major study milestones to occur on schedule. 
  • Review other site documents, information, and materials applicable to the study Review shipment procedures and records, which includes shipping documentation for products, biological samples, and other study supplies.
  • Prepare and/or review laboratory sample and product accountability reports
  • Prepare and/or review sample accountability and product accountability logs
  • Identify and mitigate, or assist in mitigating, safety and data quality risks, to include implementing, reviewing, and managing corrective and preventative actions (CAPAs)
  • Submit documents to be filed in the sponsor’s regulatory file.
  • Follow-up on monitoring visit findings until resolution.  Work to resolve findings in a timely manner to allow major study milestones to occur on schedule. 
  • Coordinate and prepare for monitoring visits for single and multi-site studies.
  • Prepare clinical monitoring reports that document all clinical monitoring activities and findings.
  • Provide feedback on monitoring reports prepared by other clinical monitors.
  • Provide verbal and written input and subject matter expertise to ORA and external study teams.
WHAT YOU’LL NEED TO SUCCEED:
  • Bachelors degree, 4+ years’ experience supporting clinical research
  • Experience developing, implementing, and maintaining clinical monitoring plans
  • Experience performing onsite and/or remote clinical monitoring activities (travel when necessary)
  • Experience reviewing electronic source documents, electronic Case Report Forms (CRFs), preparing 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.
WHAT GDIT CAN OFFER YOU: 
  • 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 
  • Diverse, highly collaborative teams
  • Professional development, education assistance, certification and training opportunities
#GDITHealth#militaryhealth#GDITLabScienceJobs#GDITFedHealthJobs 
Work Requirements
Years of Experience

4 + years of related experience

* may vary based on technical training, certification(s), or degree

Certification

Travel Required

10-25%

Citizenship

U.S. Citizenship Required

Salary and Benefit Information

The likely salary range for this position is $72,509 - $86,250. This is not, however, a guarantee of compensation or salary. Rather, salary will be set based on experience, geographic location and possibly contractual requirements and could fall outside of this range.
View information about benefits and our total rewards program.

About Our Work

We are GDIT. A global technology and professional services company that delivers technology and mission services to every major agency across the U.S. government, defense and intelligence community. Our 30,000 experts extract the power of technology to create immediate value and deliver solutions at the edge of innovation. We operate across over 50 countries worldwide, offering leading capabilities in digital modernization, AI/ML, cloud, cyber and application development. Together with our customers, we strive to create a safer, smarter world by harnessing the power of deep expertise and advanced technology.

Join our Talent Community to stay up to date on our career opportunities and events at gdit.com/tc.

Equal Opportunity Employer / Individuals with Disabilities / Protected Veterans