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Position Summary: We have an exciting opportunity to join our team as a QA & Improvement Specialist.
In this role, the successful candidate the Quality Assurance and Improvement Specialist will be responsible for compliance quality audits of human research studies under the jurisdiction of the NYU School of Medicine HRPP, and validation of department/institute-based human research oversight programs.
Plan, conduct, and report internal quality audits, both routine and for-cause, to assure adherence to NYU School of Medicine HRPP internal procedures and local and federal requirements.
Provide recommendations on study selection, audit scope and frequency, based on study population, study type, protocol, and other risk factors.
Based on the above analysis, and working with the Quality Assurance and Improvement team, develop the audit program each year and document updates as needed. Develop periodic reports for leadership on status as compared to annual plan.
Provide timely feedback through meetings with research teams and IRB members.
Prepare suggested corrective and preventive action (CAPA) plans and review with PI and other members of the research team, track and report implementation of the corrective and preventive actions. Report all information to the Manager, QA & Improvement and Director, Research Regulatory Services and present to the IRB as per standard operating procedures.
Evaluate audit findings and prepare reports for the Director, Research Regulatory Services
Further develop and define process for performing audits at NYU School of Medicine. Ensure applicable written procedures and templates are current, complete, and accurate. Refine audit methodology and standards for not-for-cause, for cause and follow-up audits.
Assist in the management of external audits and inspections by regulatory agencies and business partners.
Conduct training on the clinical research process, as well as serving as a resource to researchers.
Periodically attend training necessary to retain and improve auditing and GCP knowledge/skills.
Complete other tasks as assigned by the Manager, QA & Improvement and Director, Research Regulatory Services.
Performs other duties as assigned.
Minimum Qualifications: To qualify you must have a strong familiarity with federal regulations governing human subjects research and knowledge of Good Clinical Practice. Bachelor's Degree in a scientific discipline and two (2) years industry related experience - at least two (2) years experience with internal process and system auditing (preferably related to research compliance/Good Clinical Practice) or an equivalent combination of experience and education. Experience presenting to small and large groups at various levels. Strong analytical, writing, oral communication, and customer service skills. Able to work independently with minimal supervision. IRB Professional (CIP) or other relevant certification required within 12 months of hire and eligibility.
Preferred Qualifications: Masters in a scientific discipline, Public Health or Regulatory Compliance, certification for quality professionals through the Society for Quality Assurance, the American Society for Quality, or other formal certification in Good Clinical Practice regulatory training. Experience with human research compliance or study management in an academic health center setting.
Qualified candidates must be able to effectively communicate with all levels of the organization.
NYU 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. If you wish to view NYU 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.
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Internal Number: 62821749
About NYU Langone Health
NYU Langone Health, a world-class patient-centered integrated academic medical center, is one of the nation's premier centers for excellence in clinical care, biomedical research, and medical education. Located in the heart of Manhattan, NYU Langone is composed of four hospitals – Tisch Hospital, its flagship acute care facility; Rusk Rehabilitation; the Hospital for Joint Diseases, one of only five hospitals in the nation dedicated to orthopaedics and rheumatology; and Hassenfeld Children's Hospital, a comprehensive pediatric hospital supporting a full array of children's health services across the medical center – plus the NYU School of Medicine, which since 1841 has trained thousands of physicians and scientists who have helped to shape the course of medical history. The medical center's tri-fold mission to serve, teach, and discover is achieved 365 days a year through the seamless integration of a culture devoted to excellence in patient care, education and research. For more information, go to www.nyulangone.org.