• Clinical Coding Specialist III

    Job ID
    12570
    Type
    Regular Full-Time
    Company
    Fred Hutchinson Cancer Research Center
    Location
    US-WA-Seattle
    Category
    Biostatistics, Bioinformatics and Computational Biology
  • Overview

    Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. The Center’s five scientific divisions collaborate to form a unique environment for conducting basic and applied science. Vaccine and Infectious Diseases Division (VIDD) works to eliminate or minimize the impact of globally significant infectious diseases. Within VIDD is the Statistical Center for HIV/AIDS Research & Prevention (SCHARP), which provides statistical support and data management to researchers worldwide in the fight against HIV/AIDS with active studies in the U.S., Africa, Latin America, Asia and Europe. Careers Start Here.

     

    The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is seeking a Clinical Coding Specialist. This position is responsible for abstracting and coding Adverse Events (AEs) and Concomitant Medications (ConMeds) information from clinical trials data using the Medical Dictionary for Regulatory Activities (MedDRA) and WHO Drug Dictionary (WHO-DD) tools. The incumbent coordinates the collection and entry of study site-specific laboratory reference ranges and assists in the management of the lab normal range database. This position works with limited supervision in performing daily work assignments.

    Responsibilities

    • Using the clinical coding tools and other established SCHARP guidelines, select the clinical code most closely aligned with the reported term.
    • Review reported AEs and ConMeds to identify inadequate, ambiguous or unclear medical terms/medications and generate coding queries as necessary.
    • Manages queries related to coding terms, through closure; including entering queries into EDC and triaging site or Medial Monitor questions.
    • Identify MedDRA and WHO-DD coding synonyms.
    • On request, assist other member of the Clinical Coding and Safety staff or external partners with information from the MedDRA and WHO-DD Coding tools.
    • Review the coded data of junior staff to ensure coding is both correct and codes are applied consistently across all studies in accordance with established work instructions.
    • Assists study teams in tasks related to coding to ensure that databases can be declared clean and locked according to strict quality standards.
    • Participate in MedDRA and WHO-DD trainings to remain up to date on procedural and coding changes, as well as standard industry practices.
    • Participate on SCHARP working groups, special projects, and attend network meetings or study meetings as needed.
    • May contribute to the development, review and implementation of SOPs, templates and processes and other departmental and/or cross functional initiatives.
    • Assist in identifying and initiating requests for new medical terms and/or changes to the clinical dictionaries.
    • Coordinate the collection and entry of study site-specific laboratory reference ranges. Assist in managing the lab normal range database and subsequent EDC systems involving entry of laboratory reference ranges.
    • Train and mentor junior staff in lab normal range database management and clinical coding.
    • Conduct clinical coding dictionary up-versions across multiple protocols and EDC systems.
    • Works independently on daily activities with minimal supervision. Has a comprehensive understanding of job scope and demonstrates good judgment and capability in managing time and multitude of tasks.

    Qualifications

     

    • Bachelors or higher required, in related field desired
    • Minimum of five years of Data Management experience in clinical trials
    • Minimum of five years of experience performing clinical coding in clinical trials and knowledge of MedDRA and WHO Drug coding practices
    • Fully conversant of Clinical Coding Dictionaries (MedDRA and WHO Drug) and best Clinical Data Management practices
    • Knowledge of and experience with clinical coding dictionaries and terminology, developing and maintaining coding guidelines, quality control processes and auditing procedures
    • Familiarity with GCP, ICH and FDA requirements as they apply to clinical data
    • Strong, demonstrated technical skills (EDC systems, MS Excel, Word, PowerPoint), Medidata Coder and Medidata Lab Admin experience desired
    • Regular interaction with Data Management, Safety and Medical Management Groups
    • Excellent written and oral communication skills

    Our Commitment to Diversity

    We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We are proud to be an Equal Opportunity and VEVRAA Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability, marital or veteran status, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at escmail@fredhutch.org or by calling 206-667-4700.

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