Title:
Sr. Clinical Data Coordinator
Company:
i3 Statprobe (a UnitedHealth Group company)
Location:
any i3 Statprobe office - Ann Arbor, MI, Austin, TX, Basking Ridge, NJ, Cary, NC, Eden Prairie, MN, Lexington, KY, San Diego, CA or Burlington, Ontario, Canada.
Salary:
dependent upon experience
Job Description:
i3 Statprobe focuses exclusively on providing the pharmaceutical and biotechnology industries with comprehensive, integrated data service solutions that include data capture, summary, analysis and reporting for clinical trials across all phases of research.
The Sr. Clinical Data Coordinator works with Clinical Data Managers in the process of cleaning and validating data in clinical trials.
Responsibilities
- Acts as a team member during the study start-up process by performing User Acceptance Testing of the database and providing feedback to the clinical database programmers
- Creates, reviews and processes Data Clarification Forms and updates the databases
- Sets up patient and investigator information within Oracle Clinical and Integic systems
- Performs reconciliation of SAEs
- Performs reconciliation of laboratory or any external (third party) vendor data
- Run ancillary programs (e.g., diagnostics, special listings, reconciliation discrepancy listings) used to support the review of clinical trial data
- Performs QC of database
- Assist with maintaining and updating Data Management Plans and other relevant documentation as assigned
- Assist Data Manager in preparing and distributing study status reports and other activities as requested
Qualifications
- BA/BS degree or appropriate combination of relevant education and experience
- Possesses a good understanding of the clinical data management process
- Possesses a positive attitude and works well within teams
- Possesses good coordination skills
- Demonstrated ability to quickly learn technical databases
- Strong knowledge of MS Office suite (e.g. Word, Excel)
- Working knowledge of ClinTrial and/or Inform is preferred
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