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 Centers 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 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. The specialist 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. Assists in coordinating the collection and entry of study site-specific laboratory reference ranges. Depending on experience, may also assist in the management of the lab normal range database and train and mentor junior staff.
The incumbent works with limited supervision in performing daily work assignments.
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 AE 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 members of the Clinical Coding & Safety staff or SCHARP staff with information from the MedDRA and WHO-DD Coding tools.
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 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.
Bachelors or higher required, in related field desired
Minimum of 2 years of Data Management experience in clinical trials
Minimum of 1 year of experience performing clinical coding in clinical trials and knowledge of MedDRA and WHO Drug coding practices
Familiar with Clinical Coding Dictionaries (MedDRA and WHO Drug) 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), Medidata Coder and Medidata Lab Admin experience desired
Regular interaction with Data Management Groups
Excellent written and oral communication skills
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
Knowledge of and experience with developing and maintaining coding guidelines, quality control processes and auditing procedures.
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At Fred Hutchinson Cancer Research Center, teams of world-renowned scientists and humanitarians work together to prevent, diagnose and treat cancer, HIV/AIDS and other diseases. Researchers are discovering new ways to detect cancers earlier, improve treatments, and learn how to prevent cancers from growing. Although Fred Hutchinson opened its doors in 1975, its history began about 20 years before that. In 1962 Fred Hutchinson envisioned a center devoted to studying cancer, a disease that took his brother’s life. Today Fred Hutchinson is contributing to the next waves of breakthrough treatments and prevention strategies. Fred Hutchinson collaborates with the Seattle Cancer Alliance, the National Cancer Institute, and the University of Washington.