INFORMATION: Responsible for leading oncology research staff and managing research
data, including data collection and entry, and patient enrollment for oncology pharmaceutical
and investigator-initiated studies. Reviews,
abstracts, collects, and analysis data for a specialized program or
Collection. Collects data for patients enrolled in the study and maintains data in electronic
Communication. Determines required protocol procedures for
clinic, chemo, and surgery 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 with appropriate staff.
Documentation. Obtains research source documents from
patient records. Verifies pharmaceutical
study source documents are correct including required signatures. Implements
study-specific source documents.
Entry. 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.
Organization. Prepares research charts for clinical and
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.
Auditing. Monitors for protocol compliance, including
dosing, study procedures, tumor measurement, and 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. May represent assist Data Management in an external
Training. May be responsible for providing training or
guidance to other Data Managers and staff.
Duties. Performs other
duties as needed to successfully fulfill the function of the position.
Education: Associate's Degree in a related field.
Experience: 12 months data entry and quality assurance
Equivalency/Substitution: High school diploma
or GED and 36 months data entry and quality assurance experience.
knowledge of HIPAA.
knowledge of Common Terminology Criteria for Adverse Events (CTCAE).
verbal and written communication skills.
to work as a lead and team member.
Advanced proficiency with Microsoft Office Suite,
particularly Word and Outlook.