"Lead Data Specialist"

Job Description

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

Duties:

• Data Collection. Collects data for patients enrolled in the study and maintains data in electronic data system.
• Communication. Follows required protocol procedures for clinic, chemo, and surgery and discusses issues with the supervisor.
• Documentation. Obtains research source documents from patient records. Verifies pharmaceutical study source documents are correct, including required signatures. Implements study-specific source documents.
• Data Entry. Enters data to the system to include but not limited to registration, toxicity, drug, radiation, treatment, and pathology. Meets with study staff and external monitors to clarify and correct any data entry errors.
• Organization. May assist with collection of data for internal chart review projects, to include collecting data from other sites. Assists with preparation of research charts for clinical and research team and study-specific reports and queries for investigators and administrators. Maintains study-specific data sets for toxicity and outcome measurement.
• Auditing. Assists with monitoring protocol compliance, including dosing, study procedures, tumor measurement, and disease assessment entries. Notifies supervisor of all protocol deviations. Assists with audits of study patient documents to identify protocol non-compliance and reports deficiencies to supervisor.
• Other Duties. Performs other duties as assigned by the supervisor.

Job Requirements

Required Education: High School Diploma or GED, AND: 36 months data entry and quality assurance experience.

Skills:

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

Advertised Physical Requirements:

• Physical: May be required to sit for prolonged periods of time
• Environment: Clinical office