Clinical Safety Coder - MedDRA/WHODrug

Type of Requisition:

Pipeline

Clearance Level Must Currently Possess:

None

Clearance Level Must Be Able to Obtain:

None

Suitability:

Public Trust/Other Required:

NACI (T1)

Job Family:

Medical Affairs

Job Qualifications:

Skills:

Clinical Research, MedDRA, WHODrug

Certifications:

Experience:

6 + years of related experience

US Citizenship Required:

Yes

Job Description:

GDIT's Military Health team is hiring a Clinical Safety Coder - 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.

Job Description:

The Clinical Safety Coder – MedDRA/WHOdrug encodes terms reported as adverse events and medical history as well as prior and concomitant medications using industry accepted dictionaries such as MedDRA and WHOdrug.

RESPONSIBILITIES:

• Perform coding in accordance with departmental coding conventions and SOPs.

• 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 according to project timelines.

• 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.

• May prepare change requests to the MedDRA MSSO.

• 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.

Qualifications:

• Bachelor’s degree

• Certified MedDRA Coder

• 6 years+ WHO-DD coding experience

• 2 years+ related experience in clinical research 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 cod