Data Entry

• Work collaboratively to make sure clinical data is collected, managed and reports clearly, accurately and securely.
• Record information into various study-specific data-capture systems (both electronic and paper-based).
• Provide expertise to the standardization of Clinical Data Management processes and process improvement and efficiency.
• Support the clinical study team by helping to implement standards for Data Capture and safety data, assessing the overall quality of data and identifying and advancing key data issues, trends or patterns that may pose overall study compliance and/or data quality concerns, e.g., frequency of queries and protocol deviations.
• Oversee the development of data validation specifications and programs for assuring the accuracy of clinical trial data, e.g., data review guidelines, computerized edit check programs.
• Coordinate the review of clinical data, analysis tables/listings/figures, and patient profiles for data consistency and accuracy.
• Able to use clear judgment to tackle problems and to call out issues with proposed solutions, as necessary.
• Must ensure SOP and regulatory compliance with FDA regulations, GCP, ICH guidelines and Good Clinical CDM Practices.

Job Type: Full-time

Schedule:

• 8 hour shift

Education:

• Bachelor's (Preferred)

Experience:

• Data Entry: 1 year (Required)
• Data Entry/medical field: 1 year (Required)

Language:

• Spanish (Required)
• English (Required)

Work Location: In person