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EDC Database Builder

NYU Langone

EDC Database Builder

New York, NY +1 location
Full Time
Paid
  • Responsibilities

    NYU GROSSMAN SCHOOL OF MEDICINE is one of the nation's top-ranked medical schools. For 175 years, NYU Grossman School of Medicine has trained thousands of physicians and scientists who have helped to shape the course of medical history and enrich the lives of countless people. An integral part of NYU Langone Health, the Grossman School of Medicine at its core is committed to improving the human condition through medical education, scientific research, and direct patient care. For more information, go to med.nyu.edu, and interact with us on LinkedInGlassdoorIndeedFacebookTwitter and Instagram.

    POSITION SUMMARY: We have an exciting opportunity to join our team as a EDC Database Builder. In this role, the successful  EDC Database Builder  will join NYULHs DataCore, an innovative organization that utilizes state-of-the-art technology and informatics products to meet the clinical research needs of a prestigious institution. Reporting to the Functional Manager, s/he will develop/configure clinical research systems, and maintain the study setup metadata specifications including Electronic Data Capture (EDC), Interactive Response Technology (IRT), electronic Clinical Outcome Assessment (eCOA), electronic Patient-reported Outcome (ePRO), and Clinical Trial Management System (CTMS) for clinical research studies. S/he will also collaborate with study Project Managers and Data Managers to assess and fulfill the data extraction, transformation, reporting, and analytics requirements of clinical research studies. In particular, s/he will support studies within NYULHs Department of Psychiatry and the Early Phase Pain Investigation Clinical Network (EPPIC-Net) Program Data Coordinating Center. The Center for Alcohol Use Disorder and PTSD research is a growing, fast-paced program within NYULHs Department of Psychiatry. The current portfolio of studies is comprised of databases in all stages - initiation/start-up, close-out, and follow-up (maintenance) - for several large, federally-funded grants, innovative industry sponsored projects, and the Department of Defense with interface within the established Systems Biology Consortium leadership group (i.e., Harvard, UCSF, WRAIR, etc.) EPPIC-Net is a network that includes a Data Coordinating Center (DCC), Clinical Coordinating Center (CCC), and ten Specialized Clinical Centers (SCCs). The EPPIC-Net DCC works with Federal government partners to conduct high-quality efficient clinical trials to develop non-addictive treatments for pain as part of the Helping to End Addiction Long-term (HEAL) initiative. The DCC provides a range of coordinating services for this NIH-funded network, including study design; collection of clinical, biomarker and imaging data; data management; statistical analysis; and establishment of repositories for bio-specimens and biomedical images.

    JOB RESPONSIBILITIES:

     

    • With minimal oversight, work with study teams to finalize database build specifications, program eCRFs in EDC system (e.g. TrialMaster, REDCap, etc.) within project timelines. Collect User Acceptance Testing (UAT) findings and modify the database as necessary until all issues are resolved.
    • Troubleshoot system/software problems through resolution.
    • When necessary, work with the project and system administration teams to identify and implement any project specific roles and permissions needed for the project.
    • Develop data extraction programs/routines for data transfer to authorized agencies or individuals.
    • Develop standard and ad hoc query reports for data integrity monitoring and project management purposes.
    • Program reports, including listings, summary tables, and graphics for assigned studies and projects.
    • Contribute to the development of strategic plans for new projects and facilities; serve in an advisory capacity on database procedures and best practices.
    • Contribute to establishing procedures and best practices for implementation of data standards.
    • Ensure compliance with external and internal regulations and policies governing data management and data systems, including, but not limited to, good clinical practice (GCP), Food and Drug Administration (FDA) and organizational standard operating procedures (SOPs).
    • Provide consultation and administer training for users on the operation of clinical trial systems and tools.
    • Performing internal QA testing

     

     


     

    MINIMUM QUALIFICATIONS: To qualify you must have a Bachelor's degree in Computer Science or related field with at least 4 years related experience. Experience with electronic data capture (EDC) and database management systems (e.g., REDCap, Medidata, TrialMaster, Inform, etc.).In-depth understanding of data collection, data flow management, data quality, data extraction and data standards (knowledge of CDISC standards for CDASH, SDTM and ADaM a plus).

    PREFERRED QUALIFICATIONS: Proficiency in JavaScript and/or other scripting language Experience developing EDCs in Anju TrialMaster

    Qualified candidates must be able to effectively communicate with all levels of the organization. NYU Grossman School of Medicine provides its staff with far more than just a place to work. Rather, we are an institution you can be proud of, an institution where you'll feel good about devoting your time and your talents. NYU Grossman School of Medicine is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sex, sexual orientation, transgender status, gender dysphoria, national origin, age, religion, disability, military and veteran status, marital or parental status, citizenship status, genetic information or any other factor which cannot lawfully be used as a basis for an employment decision. We require applications to be completed online. If you wish to view NYU Grossman School of Medicine's EEO policies, please click here. Please click here to view the Federal "EEO is the law" poster or visit https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm for more information. To view the Pay Transparency Notice, please click here.

    NYU Langone Health provides a salary range to comply with the New York City Law on Salary Transparency in Job Advertisements. The salary range for the role is $61,475.67 - $85,000.00 Annually. Actual salaries depend on a variety of factors, including experience, specialty, education, and hospital need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.

    Required Skills Required Experience

  • Locations
    New York, NY • New York, NY