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

Posted in Management 30+ days ago.

Type: Full-Time





Job Description:

POSITION
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
project.  


REPRESENTATIVE
DUTIES:


  1. Data
    Collection.
     
    Collects data for patients enrolled in the study and maintains data in electronic
    data system

  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.

  4. 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.

  5. 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.

  6. 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
    audit.

  7. Training.  May be responsible for providing training or
    guidance to other Data Managers and staff.

  8. Other
    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
experience. 


Equivalency/Substitution:   High school diploma
or GED and 36 months data entry and quality assurance experience.


Knowledge/Abilities/Skills:


  • 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.