Responsible for managing research data, including data collection and entry, and patient enrollment for pharmaceutical and investigator-initiated studies. Performs the review, abstraction, collection, and analysis of data for a specialized program or project. 

• Collects data for patient enrollment and maintains electronic data system
• Determines required protocol procedures and discusses required information with clinic, chemo, and research staff. 
• Serves as liaison between site and sponsor regarding data issues and discusses data issues or discrepancies to appropriate staff.
• Obtains research source documents from patient records. 
• Verifies pharmaceutical study source documents have appropriate signatures and are correct for the pharmaceutical studies and cooperative group. 
• Develops and implements study-specific source documents.
• Assists with data entry of registration, toxicity, drug, radiation, and pathology data. 
• Meets with external monitors to clarify and determine data entry corrections.
• Assist management in prioritization of data volume and timeliness.
• Prepares research charts for clinical and/or research team. 
• Prepares advanced study-specific reports and queries and discusses with investigators and administrators, including collecting data from other sites. 
• Coordinates specimen and tissue submissions with Biorepository staff.
• Collaborates with investigators to collect data for internal chart review projects and to maintain study-specific data sets for toxicity and outcome measurement. 
• Develops action plans to address research deficiencies with staff.
• Monitors for protocol compliance, including dosing, study procedures, tumor measurement, and/or disease assessment entries. 
• Notifies management and regulatory specialist of all protocol deviations. 
• Audits study patient documents to identify protocol non-compliance and develops action plans to address deficiencies. 
• Represents Data Management in external audit.
• Performs other duties as needed to successfully fulfill the function of the position.

Education:

High School diploma or GED.

Experience:

24 months data entry and quality assurance experience. Advanced degree of proficiency with Microsoft Office Suite, particularly Word and Outlook.

Certifications or Licenses:

• None

• Knowledge of HIPAA
• Ability to code Common Terminology Criteria for Adverse Events (CTCAE)
• Ability to communicate in orally and in writing

Physical:
Ability to engage in repetitive motions. Must be able to sit for prolonged periods of time.

Environmental:
Standard office environment.