• Clinical Coding Specialist

    Job ID
    11626
    Type
    Regular Full-Time
    Company
    Fred Hutchinson Cancer Research Center
    Location
    US-WA-Seattle
    Category
    Clinical Research Support Services
  • 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. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first and largest cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

     

    The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is seeking a Clinical Coding Specialist to abstract and code Adverse Events (AEs) and Concomitant Medications (ConMeds) information from clinical trials Case Report Forms (CRFs)  using the Medical Dictionary for Regulatory Activities (MedDRA) and WHO Drug Dictionary (WHO-DD) tools. The Clinical Coding Specialist will assist in coordinating the collection and entry of study site-specific laboratory reference ranges.

    Responsibilities

    1. Using the clinical coding tools and other established SCHARP guidelines, select the clinical code most closely aligned with the reported term.
    2. Review reported AEs and ConMeds to identify inadequate, ambiguous or unclear medical terms/medications and generate coding queries as necessary.
    3. Manages queries related to coding terms, through closure; including entering queries into EDC and triaging site or Medial Monitor questions.
    4. Review coded data to ensure coding is both correct and codes are applied consistently in accordance with established standard operating procedures and guidelines.
    5. Upon request, assist other members of the Clinical Coding and Safety group or SCHARP staff with information from the MedDRA and WHO-DD Coding tools.
    6. Participate in SCHARP working groups and special projects as needed.
    7. Participate in MedDRA and WHO-DD trainings to remain up to date on procedural and coding changes, as well as standard industry practices.
    8. Assist and provide coverage, as needed, in coordinating the collection and entry of study site-specific laboratory reference ranges.
    9. Conduct all job duties within context of Good Clinical Practice (GCP) and according to SCHARP SOPs and guidelines.
    10. Normally receives detailed instructions on all work.

    Qualifications

    Minimum:

    • Bachelor's Degree or higher required and a minimum of 1 year of data management experience in clinical trials
    • Experience with EDC Systems, MS Excel, Word, PowerPoint
    • Excellent written and oral communication skills

     

    Preferred:

    • BA/BS degree in a related field
    • 4+ years of data management experience in clinical trials
    • 3+ 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
    • Experience with developing and maintaining coding guidelines, quality control processes and auditing procedures
    • Familiarity with GCP, ICH and FDA requirements as they apply to clinical data
    • Medidata Coder and Medidata Lab Admin experience desired.

    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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