Clinical Coding Specialist II-III

Job ID
20750
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 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.


At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.



The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Clinical Coding Specialist II-III. CCS 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 (WHODrug) tools. Coordinates the collection and entry of study site-specific laboratory reference ranges and assists in the management of the lab normal range database. Train and mentor junior staff.

Responsibilities

Level II

  • Using the clinical coding tools and other established SCHARP guidelines, select the clinical code most closely aligned with the adverse event being reported.
  • Review reported AEs and ConMeds to identify inadequate, ambiguous or unclear medical terms/medications and generates coding queries as necessary.
  • Manages queries related to coding terms, through closure; including entering queries into EDC and triaging site or Medial Monitor questions.
  • Review coded data to ensure coding is both correct and codes are applied consistently across all studies in accordance with established work instructions.
  • On request, assist other Clinical Coding & Safety staff or SCHARP staff with information from the MedDRA and WHODrug Coding tools.
  • Participate in MedDRA and WHODrug trainings to remain up to date on procedural and coding changes, as well as standard industry practices.
  • Participate on SCHARP working groups and special projects, as needed.
  • Assists in coordinating the collection and entry of study site-specific laboratory reference ranges.
  • Conduct all job duties within context of Good Clinical Practice (GCP) and according to SCHARP SOPs and guidelines.
  • Works mostly independently on daily activities with minimal instruction. Exercises good judgment within scope of responsibilities to determine appropriate actions.


Level III

  • Using the clinical coding tools and other established SCHARP guidelines, select the clinical code most closely aligned with the adverse event being reported.
  • Review reported AEs and ConMeds to identify inadequate, ambiguous or unclear medical terms/medications and generates 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 WHODrug coding synonyms.
  • On request, assist the Clinical Coding and Safety staff or external partners with information from the MedDRA and WHODrug 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 WHODrug trainings to remain up to date on procedural and coding changes, as well as standard industry practices.
  • Participate in 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.
  • 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

MINIMUM QUALIFICATIONS:

 

Level II

  • Bachelors degree or higher required, in related field desired.
  • Minimum of two years of Data Management experience in clinical trials.
  • Minimum of one year of experience performing clinical coding in clinical trials and knowledge of MedDRA and WHODrug coding practices.
  • Familiar with Clinical Coding Dictionaries (MedDRA and WHODrug) and best Clinical Data Management practices.
  • Knowledge of and experience with clinical coding dictionaries and terminology.
  • Familiarity with GCP, ICH and FDA requirements as they apply to clinical data.
  • Demonstrated technical skills (EDC systems, MS Excel, Word, PowerPoint).
  • Regular interaction with Data Management Groups.
  • Excellent written and oral communication skills.

 

Level III

  • Bachelors degree or higher required, in related field desired.
  • Minimum of four years of Data Management experience in clinical trials.
  • Minimum of three years of experience performing clinical coding in clinical trials and knowledge of MedDRA and WHODrug 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).
  • Regular interaction with Data Management, Safety and Medical Management Groups.
  • Excellent written and oral communication skills.

 

PREFFERED QUALIFICATIONS:

  • Medidata Coder and Medidata Lab Administration experience desired.

 

Fred Hutch has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations.
As a condition of employment, newly hired employees must provide proof of vaccination or initiate the accommodations process before their first day of employment. 

 

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

Our Commitment to Diversity

We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, 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 hrops@fredhutch.org or by calling 206-667-4700.

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