Clinical Documentation Associate II

Employer
AbbVie
Location
Lake County, IL, US
Posted
Oct 10, 2018
Ref
1807425
Required Education
Bachelors Degree
Position 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