• Data Quality Analyst ll

    Location US-MA-Boston
    Job Posted Date 2 weeks ago(10/3/2018 2:09 PM)
    Job ID
    2019-12727
    Category
    Clinical Research
    Type
    full time
    Grade
    21
  • Overview

    Located in Boston and the surrounding communities, Dana-Farber Cancer Institute brings together world renowned clinicians, innovative researchers and dedicated professionals, allies in the common mission of conquering cancer, HIV/AIDS and related diseases. Combining extremely talented people with the best technologies in a genuinely positive environment, we provide compassionate and comprehensive care to patients of all ages; we conduct research that advances treatment; we educate tomorrow's physician/researchers; we reach out to underserved members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.

     

    The Office of Data Quality (ODQ) provides research support to the Dana-Farber/Harvard Cancer Center with a focus on quality assurance, quality control, and process improvement. Functions of ODQ include protocol subject registration and randomization, clinical research auditing, data and safety monitoring, quality control of DF/HCC initiated clinical trial data, national protocol and investigator registrations, DF/HCC multi-center coordination oversight, participation in general clinical trials education, and committee management.  The Data Quality Manager supervises all Data Quality Analysts. The Data Quality Manager reports to the Director of ODQ.

     

    The Data Quality Analysts work closely with investigators, research teams, and biostatisticians to ensure the integrity and quality of clinical trial data. Data Quality Analysts monitor the timely submission and completeness of clinical trial data entry, perform edit checks on the data, issue and resolve data queries, and perform other quality control and data cleanup tasks.

     

    Responsibilities

    • Ensures clinical trial data collected throughout the conduct of a protocol are complete and accurate.
      • Using InForm EDC, reviews data captured on electronic case report forms to verify completion per protocol requirements.
      • Reviews program-generated queries and responses, reissues queries as appropriate, and closes queries upon resolution.
      • Generates query reports for distribution to study teams.
      • Performs logical edit checks on the data and reviews trends in the data to identify potential errors. Manually issues queries in response.
      • Performs other related quality control tasks to identify discrepancies and violations. Reports findings to investigators or ODQ leadership as appropriate.

    • Manages the collection and entry of clinical trial data on paper case report forms.
      • Collects completed case report forms from research teams.
      • Performs quality control activities on the collected data, requests clarifications as appropriate.
      • Enters data from paper case report forms into electronic systems.

    • Monitors completeness and timeliness of clinical trial data entry.
      • Generates monthly/quarterly missing data reports for distribution to research teams.
      • Reviews missing data reports for significant non-compliance and notifies investigators or ODQ leadership as appropriate.
      • Generates data reports for review by DF/HCC oversight committees (e.g., DSMB, DSMC)

    • Acts as a resource for investigators and study teams for items related to clinical trial data
      • Communicates directly with investigators and research teams regarding discrepancies and data entry processes.
      • Provides superior customer service when handling research team requests and responding to questions.
      • Guides research teams and investigators by encouraging best practices and assisting in the education of study team members on protocol-specific data entry requirements.
      • Coordinates with research teams to prepare data for analysis and/or study completion.

    • Verifies the accuracy and completeness of information within various systems that support clinical trial operations
      • Reviews critical data fields in the OnCore Clinical Trials Management System to ensure accuracy and consistency with institutional and departmental policies
      • Performs quality control activities on data present in various systems to identify errors or discrepancies
      • Generates reports from various systems for comparison and to aid in the conduct of quality control processes

    Qualifications

    • Bachelors of Science/Arts required with at least 2 years of relevant work/research experience.
    • Familiarity with regulatory requirements and best practices related to the conduct of human subject research (e.g., FDA regulations, ICH GCP).
    • Experience with electronic data capture systems and electronic case report forms (InForm preferred).
    • Knowledge and/or experience in data management or quality control is a plus.
    • Ability to communicate clearly and effectively with written and verbal English.

    Knowledge, Skills, Abilities:

    • Complex problem solving skills.
    • An ability to work independently.
    • Knowledge of clinical trial regulations and procedures, data management processes and database-related technical skills.
    • In addition to the above, has progressed to performing more advanced quality control processes.
    • Has a strong understanding of data management processes, and is able to resolve complex issues and questions independently.
    • Able to provide input on overall data quality planning, procedures, and systems with an eye towards consistent improvement.
    • Able to handle some projects independently, and work with Senior Data Analysts and/or the Data Quality Manager on larger projects.

    Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other groups as protected by law.

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