CLINICAL CODING ASSOCIATE

Clinical Coding Associates utilize medical and clinical knowledge to code clinical Adverse Events and Concomitant Medications to standard dictionaries (e.g., MedDRA, WHO-Drug), and to reconcile Serious Adverse Events with clinical safety databases. They are also responsible for coordinating dictionary updates with the technical team in order to comply with global regulatory requirements and corporate SOPs.
Essential Functions:
1. Code Adverse Event and Medication data to standard dictionary terminologies in accordance with Corporate Safety Monitoring and Clinical Data Management SOPs.
2. Maintain the dictionaries in a compliant state by coordinating updates with the technical support group.
3. Reconcile serious adverse events with the global safety database in accordance with Corporate Safety Monitoring SOPs..
4. Provide listings of coded AEs and concomitant medication data to the appropriate regulatory staff for regulatory submissions.
5. Maintain current regulatory and technical knowledge and communicate requirements to management.
6. Provide training and direction to other coding staff.


Requirements:

Education required/ preferred: RN (BSN or MSN preferred) with MedDRA and WHO-Drug coding experience
Experience: 5-8 years of adverse event coding experience in a clinical research environment. Solid knowledge of ICH/GCP/FDA regulations and guidelines as they pertain to clinical data coding.
Preferred Skills/Qualifications: Oracle Clinical and TMS coding, Preferred therapeutic areas of experience in imaging and pharmaceuticals (branded and generic).
Skills/Competencies: Oracle Clinical, TMS, medical terminology
Other Skills: Good oral and written communication skills, project management skills, knowledge of SQL or SAS programming, or willingness to learn.
Travel up to 10%




To apply online, please use the following link: