Information Analyst II
Location: School of Medicine & Dentistry
Full/Part Time: Full-Time
Full Time 40 hours Grade 052 Neuro-Ctr Human Exp Ther/CTCC
8 AM-5 PM; OCCAS WKENDS
Incumbent will be responsible for ensuring, analyzing and interpreting the accuracy and consistency of clinical databases. Disseminate information to study investigator(s), team members, Steering Committees and Sponsors. Develop, document and implement data management processes and ensure compliance with all applicable regulatory and departmental SOPS, regulations and guidelines.
- Writes Data Management Plan(s).
- Receives/Reviews/Tracks Case Report forms (CRFs).
- Supports Clinical Systems Application.
- Develops study CRFs, worksheets and source documents per protocol.
- Reviews CRF Design with forms Designer.
- Specification of data validation/edit check rules.
- Reviews CRF data against the clinical database for assigned protocols.
- Query management: Reviews, identification and dissemination of data clarifications to investigate sites (reviews and resolves with off-site personnel). Analyzes and interprets query resolutions.
- Communicates with study team regarding trial information.
- Auto/manual coding of study adverse events, secondary diagnoses, and concomitant medications using international regulatory coding dictionaries (WHO, MedDRA). Analyzes coding reports for consistency, disseminates coding reports.
- Oversees locking of the database at study completion, ensuring databases are validated and ready for transfer and/or statistical analyses.
- Direct interaction with study sponsor.
- Specification and implementation of data validations/edit checks.
- Performs study implementation unit testing, screen flow testing, derivation testing, development of consistency check scripts, performs consistency check testing, performs study production qualification run.
- Ad-hoc reports using Clinical data Management System tools and reports.
- Monitors clinical sites performance.
- Facilitates Medical Monitor review of coding reports. Reconciles serious Adverse Events data to clinical data.
Bachelor's degree in health related discipline, social science or technical discipline preferred. Three to five years experience in clinical research methods and clinical data management is required. Must be detail oriented, highly organized, and possess good interpersonal and communication skills. The ability to work effectively in a team environment as well as alone is required. Advanced familiarity/experience with computers is required. Proficiency in use of relational database (CCDM Certification) is preferred.
How To Apply
All applicants must apply online.
The University of Rochester is an Equal Opportunity Employer.