Clinical Documentation Associate II - Remote

Overview

The Clinical Documentation Associate II is responsible for managing and ensuring inspection readiness of clinical documentation and master files, serving as the CDC representative on study teams.

In Short

• Manage and ensure inspection readiness of clinical documentation and master files.
• Perform quality control of the Trial Master File (TMF).
• Collaborate with artifact owners and study team members.
• Develop and maintain study-specific TMF structure documentation.
• Prepare TMFs for audits and inspections.
• Contribute to continuous improvement projects.
• Provide input to SOPs and Work Instructions.
• Comply with GCP and AbbVie SOPs.

Requirements

• Bachelor's degree required with a minimum of 2 years relevant industry experience.
• Proven analytical and critical thinking skills.
• Good oral and written communication skills.
• Ability to manage multiple projects simultaneously.
• Competent knowledge of clinical documentation procedures.
• Ability to work independently in clinical documentation systems.

Benefits

• Comprehensive benefits package including paid time off.
• Medical, dental, and vision insurance.
• 401(k) plan for eligible employees.
• Participation in short-term incentive programs.