EDC/eCRF developer

NYU Langone Health New York, NY

About the Job

NYU Grossman School of Medicine is one of the nation's top-ranked medical schools. For 175 years, NYU 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 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 Facebook, Twitter and Instagram.

Position Summary:
We have an exciting opportunity to join our team as a EDC/eCRF developer.

In this role, the successful candidate EPPIC-Net is a network that will include a Data Coordinating Center (DCC), Clinical Coordinating Center (CCC), and ten Specialized Clinical Centers (SCCs). The DCC will work 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 will provide a range of coordinating services for this NIH-funded network, including statistical and data management; collection of clinical, biomarker and imaging data; and establishment of repositories for biospecimens and biomedical images.
The EDC/eCRF Developer will work closely with the EPPIC-Net DCCs Principal Investigator, Data Management Leadership, and key stakeholders to coordinate the development and maintenance of electronic case report forms (eCRFs) and program study databases. S/he will also administer access to and provide end-user support for the electronic data capture system. Lastly, s/he will play a key role in ensuring the timely completion of assigned studies while adhering to established clinical trial standards and study budgets.

Job Responsibilities:

  • Understand and translate end-user and study-specific requirements into design; work closely with Principal Investigators and study teams to develop and maintain data dictionaries and EDC specifications; prepare data matrices, standard and ad-hoc operational reports; develop specifications and implement in-database operational reports (e.g., enrollment rates, enrollment demographics); train end-users in data entry; prepare data entry guidelines document for CRFs.
  • Perform requirements analysis to ensure that eCRFs and database meet both best practices standards and EPPIC-Nets standard CRF domains; program study eCRFs within the EDC system
  • Design and develop CRFs and data dictionaries; revise CRFs and supporting data dictionaries in compliance with SOPs and regulatory requirements; review all modifications to CRFs and study databases at all phases of development; document changes to CRFs and schedules of assessment; conduct quality assurance testing when changes are made to study databases; ensure highest possible level of research study data integrity by reviewing study data for completeness and accuracy; initiate data queries and oversee data query resolution from initiation through completion.
  • Work with EPPIC-Nets Clinical Data Managers and hub/site personnel to identify post-production changes to the eCRFs/study database based on commonly identified issues and feedback; ensure that all post-production changes to the eCRFs have received the necessary approvals from study leadership; document, test, and implement post-production changes to the study database
  • Test and validate electronic data capture (EDC) systems, registries, websites, and other informatics systems and products; test and document accuracy of processing, storage, and querying of variables in all electronic data capture (EDC) and web systems prior to use in studies.
  • Administer and maintain user access to study databases and restore access to and functioning of study databases in the event of service interruptions; manage user request for systems modifications and reports development; troubleshoot system/software problems through resolution.
  • Develop and conduct training on data management policies, procedures, and best practices; assist in developing SOPs for data tracking and quality assurance and in establishing and/or implementing data standards (e.g., CDASH, SDTM); ensure compliance with external and internal regulations and policies governing data

Minimum Qualifications:
To qualify you must have a Typically requires 3 or more years of experience and BA/BS degree or equivalent

Preferred Qualifications:
Experience with EDC software such as REDCap and other commercial systems (e.g., Oracle Clinical, Medidata, Inform, TrialMaster, Velos, etc.)

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 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.
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