Clinical Documentation Associate II job in Lake County
|Category:||Research and Development|
|Job Type:||Full Time|
• Active study team member for assigned studies.
• Ensures real-time inspection readiness of clinical documentation by collaborating with Artifact Owners, reviewing assigned TMFs to ensure accuracy and completeness, and tracking and reporting status to study team(s).
• Develops and updates study-specific TMF structure documentation.
• Provides support for audits/inspections
• Update CTMS in a contemporaneous manner.
• Collaborates with CDC Operations colleagues.
• Complies with GCP, AbbVie SOPs and functional area processes.
• For assigned countries, may lead and execute study start-up activities including but not limited to:-Prepare submissions to central Ethics Committees. -Review documents and assemble packet required for IP release.
• Bachelor degree or international equivalent is required
• With at least 2 years Pharma experience or professional equivalent.
• Demonstrates analytical and critical thinking skills.
• Operates with limited oversight
• Good oral and written communication skills.
• Working knowledge of clinical documentation business procedures .
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)