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Oncology Data Specialist - Early Phase at University of Oklahoma in Oklahoma City, Oklahoma

Posted in Management 30+ days ago.

Type: Full-Time





Job Description:



Position Information: Responsible for coordinating oncology research activities and managing Early-Phase Oncology Clinical Trials 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 project.

Essential Duties:




  1. Data Collection. Collects data for patients enrolled in the study and maintains data in electronic data system. Updates and submits data within specific timeline.  





  2. 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.





  3. Documentation.  Obtains research source documents from patient records.  Verifies pharmaceutical study source documents are correct including required signatures. Implements study-specific source documents.





  1. Data 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.



  2. 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.



  3. 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.  Represents Early-Phase Data Management team in an external audit.



  4. Training. Responsible for providing training or guidance to other Data Specialists and staff.





  1. Other Duties. Perform other duties as assigned by the supervisor.



Education: High School Diploma or GED.
 
Experience: 24 months data entry or quality assurance experience.
 
Knowledge, Skills & Abilies:



  • Ability to learn and understand HIPAA regulations.



  • Ability to learn and apply Common Terminology Criteria for Adverse Events (CTCAE).



  • Proficiency with Microsoft Office Suite, particularly Word and Outlook.



  • Must be able to communicate orally and in writing.



  • Ability to work as a team member.



  • Great typing skills.


Preferences:



  • Quality assurance experience.



  • Candidate with an Associate's Degree, Bachelor's Degree, or Master's Degree in a related field.






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