Data Assistant FSM/CC

Job Description

Job Summary:Ensures submission and maintenance of accurate, timely, complete and reliable data and reports by implementing data management and quality assurance procedures. Provides feedback to customers and clients regarding systematic data errors or problems. Documents revisions in codebooks and manuals.

Responsible for the compilation of all data for clinical trials managed by the CTO. Manages project data including extraction, entering, processing, accuracy, analysis and evaluation of data ensuring that results meet project information and deliverable objectives. Serves as a resource to new staff regarding quality data entry, maintenance, and departmental policies. Assists with data for all teams and occasional audits.

Partners with internal/external project and IT staff to create, review, analyze,interpret, summarize and prepare progress and final reports. Provides consultation to internal/external project staff on appropriate data management, methodological issues and analysis of dataSpecific Responsibilities:Strategic PlanningParticipates in team and other departmental meetings to share experiences, learn about what other teams are doing and help solve problems.

AdministrationManages data receipt, tracking and follows up on assigned project(s). Detects trends and reports on patterns of errors. Contacts customers to obtain missing data.

Compiles and maintains codebooks, data files and memos needed for subsequent analysis of data. Learns and complies with appropriate compliance and regulation requirements regarding protected data. Obtains required training for all electronic data capture systems.

Gives input on CTO policies and procedures with regards to data entry/monitoring. Assesses protocol compliance and communicates directly with the study coordinator and PI when compliance issues are identified.

DevelopmentEdits, codes and enters data per protocol. Runs reports and completes basic analysis. Determines data needed to be collected and the appropriate data resources for specific study/project needs.

Abstract all required patient data from medical record sources for entry into cas report forms (paper and/or electronic). Main contact for monitors/CRO’s for data query resolution. PerformanceReviews data input for accuracy, addressing on skip patterns, coding, and other information.

Performs cleaning/formatting tasks of datasets. Follow timelines stated in SOP (CO-SM-312) and individual sponsor contracts, for data entry and query resolution. Assists with data reconciliation.

Miscellaneous Performs other duties as assigned. Minimum Qualifications:A high school diploma or equivalent is required. 2 years’ data entry or similar experience is required.

EWJD3