- Collects data for patients enrolled in the study and maintains data in electronic data system
- 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.
- Obtains research source documents from patient records. Verifies pharmaceutical study source documents are correct including required signatures. 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 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.
- 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 audit.
- May be responsible for providing training or guidance to other Data Managers and staff. Performs other duties as needed to successfully fulfill the function of the position.
- 36 months data entry and quality assurance experience in an oncology research environment.
- Knowledge of HIPAA
- Working knowledge of HIPAA
- Working knowledge of Common Terminology Criteria for Adverse Events (CTCAE) Excellent verbal and written communication skills
- Ability to work as a lead and team member
- Advanced proficiency with Microsoft Office Suite, particularly Word and Outlook
- Physical: Must be able to sit for prolonged periods of time.
- Environmental: Standard office environment
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Sr. Oncology Data Specialist - Norman, United States - The University of Oklahoma
Description
OU Health Stephenson Cancer Center is Oklahoma's only National Cancer Institute (NCI)-Designated Cancer Center, and one of only 72 NCI-Designated Cancer Centers in the United States.
This highly competitive accreditation ensures that our patients receive the highest standard of care and have access to the most advanced cancer treatment options.
At the Stephenson Cancer Center, we have an exciting new job opportunity that could be right for you The Senior Oncology Data Specialist is responsible for leading staff and managing research data, including data collection and entry, and patient enrollment for pharmaceutical and investigator-initiated studies.
Learn more about the Stephenson Cancer Center's Clinical Trials Office here.
Duties:
Required Education:
High School diploma or GED AND:
Skills:
Working Conditions:
Why You Belong at the University of Oklahoma: The University of Oklahoma fosters an inclusive culture of respect and civility, belonging, and access, which are essential to our collective pursuit of excellence and our determination to change lives.
The unique talents, perspectives, and experiences of our community enrich the learning, and working environment at OU, inspiring us to harness our innovation, creativity, and collaboration for the advancement of people everywhere.
Equal Employment Opportunity Statement:
The University of Oklahoma, in compliance with all applicable federal and state laws and regulations, does not discriminate based on race, color, national origin, sex, sexual orientation, genetic information, gender identity, gender expression, age, religion, disability, political beliefs, or status as a veteran in any of its policies, practices, or procedures.
This includes, but is not limited to, admissions, employment, financial aid, housing, services in educational programs or activities, and health care services that the University operates or provides.