GDITs Military Health team is hiring a Clinical Coding Specialist - MedDRA/WHODrug 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
Collaborate with project team during study startup to ensure proper coding setup.
Create and maintain standard test data for validation of coding tool and interface to database.
Perform user acceptance testing of coding system and database for each study going into production.
Configure coding tool for each study with appropriate dictionaries and versions per DMP.
Create project-specific eCRF guidelines for capturing safety data and train sites for each trial.
Provide completed medical coding reports using Medical Dictionary for Regulated Activities and World Health Organization Drug Dictionary per the FDA and industry guidance, completed CRFs and related queries and audit trail reports, which document resolved queries during study conduct and closure and all database changes, the reasons data were changed/updated, timestamps (date and time), and who made the changes during study conduct and closure activities
Generate and resolve data queries for clarification of data to be coded.
Create project-specific coding conventions as necessary in collaboration with Principal Investigator.
Oversee/review external coding (from vendors and other commands) and provide feedback.
Create and QC coding reports, coordinate PI coding review, and ensure all approvals are obtained.
Create SAE listings, coordinate SAE reconciliation with Safety group, ensure approvals are obtained.
Collaborate to implement dictionary version/format upgrades, such as WHODrug Global C3 format.
Develop and present two day hands-on internal coding training.
Develop/maintain standard ORA coding guidelines, coding process instructions, eCRF safety data guidelines, protocol-specific coding conventions template, and coding report templates
Contribute to SOPs and coding working practices, create/maintain instructions for backup coder.
Communicate with FDA regarding regulations/guidelines related to clinical coding.
Contribute to ongoing improvement and streamlining of coding processes.
Troubleshoot and consult with project team to resolve all system and coding issues.
Minimum 2 years of related experience creating CRF guidelines and project specific coding conventions
Experience reviewing clinical protocols
Experience communicating with FDA regarding regulations/guidelines related to clinical coding.
Experience create/maintain standard test data for testing coding tool and interface with database.
Experience assigning MedDRA/WHODrug dictionary codes to specified clinical trial data/generate queries per guidelines.
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:
401K with company match
Customizable health benefits packages
Internal mobility team dedicated to helping you own your career
Challenging work that makes a real impact on the world around you
Full-flex work week
We are GDIT. The people supporting some of the most complex government, defense, and intelligence projects across the country. We deliver. Bringing the expertise needed to understand and advance critical missions. We transform. Shifting the ways clients invest in, integrate, and innovate technology solutions. We ensure today is safe and tomorrow is smarter. We are there. On the ground, beside our clients, in the lab, and everywhere in between. Offering the technology transformations, strategy, and mission services needed to get the job done.
GDIT is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.