AbbVie Associate I, Clinical Documentation in Lake County, Illinois
Associate I, Clinical Documentation
USA, Illinois, Lake County
1 additional location
Research & Development
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
Proven analytical and critical thinking skills.
Good oral and written communication skills.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
Job Type: Experienced