Level-Specific Responsibilities:
- Performs study status tracking, data entry, and verification.
- Performs data review and quality control procedures.
- Develops and provides input into project-specific guidelines.
- Performs data review, identification of data issues, and quality control procedures.
- Participates in User Acceptance Testing.
- Participates in the query management and data cleaning process.
- Archives all study-related documents.
- Provides advice or solutions in the area of expertise.
- May participate in audits and inspections.
- Participates in project team meetings.
Skills Required:
- Working knowledge of clinical research and the drug development process.
- Working knowledge of databases, tracking, validation, programming, word-processing, and spreadsheet software.
- Working knowledge of clinical databases and query management.
- Working knowledge of organization procedures and policies and ensures actions comply.
- Good written and oral communication skills.
- Good attention to detail.
- Good organization and time management skills.
- Ability to take a proactive approach to work.
- Ability to solve simple to moderate problems.
- Ability to multitask and prioritize work.
- Good ability to work in cross-functional teams.
- Developing professional expertise, applies company policies and procedures to resolve issues.
- Works on routine problems of moderate scope. Exercises judgment following standard practices and procedures in analyzing situations or data from which answers can be readily obtained. Builds stable working relationships internally.
- Receives occasional guidance on day-to-day work and moderate guidance on new projects or assignments.
