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POSITION SUMMARY:

We have an exciting opportunity to join our team as a Quality Assurance & Improvement.

Under the supervision of the QIA Unit Assistant Director (AD), the QIA Specialist will be responsible for conducting quality improvement reviews with researchers, maintaining best practices guidance, supporting and educating the NYU Langone Health (NYUL) research community via quality improvement activities. The QIA Specialist is also responsible for identifying issues of non-compliance with applicable laws, regulations and institutional policies of all human research studies under the jurisdiction of the NYUL Human Research Protections unit and guiding researchers on reporting to IRB and/or other stakeholders as well as advise AD regarding next steps on IRB review path.

JOB RESPONSIBILITIES:

• Provide recommendations on study selection, audit scope and frequency, based on study population, study type, protocol, and other risk factors.
• Plan, conduct, and report internal quality improvement reviews, routine and for cause audits, to assure adherence to federal, state and local regulations and all NYUL human research policies, standard operating procedures.
• Provides advice, expert guidance and education to members of the NYUL HRP including IRB and research teams.
• Provide timely feedback through meetings with the research teams and IRB members and timely completion of the
• audit report and all audit related activities.
• Evaluate findings and prepare reports for the AD’s review and sign off.
• 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 CAPA.
• Report all CAPA related completions and deficiencies (at a standard timepoint) to the AD and work with AD to present to the IRB.
• Provide support and assistance to NYUL researchers in the preparation and management of external audits and inspections by regulatory agencies and business partners.
• Based on an annual analysis, and working with the QIA team, develop and propose a QIA annual program for implementation including # and type of studies chosen for review.
• Complete reports QIA work for HRP leadership on status as compared to annual plan and prior years; including productivity metrics and aggregate results and findings. 
• Develop training material and conduct training on the clinical research process and serve as a resource to NYUL research teams.
• Provide high-level guidance and assistance to researchers and IRB members and staff through education and training.
• Complete other tasks as assigned by the AD.
• Work on special projects related to QIA and HRP as needed.
• Periodically attend training necessary to retain and improve auditing and GCP knowledge/skills.
• Functions as a collegial and efficient partner to the research community.
• Attends HRP team meetings and other ad hoc meetings as needed and collaborates across divisions when necessary.

MINIMUM QUALIFICATIONS:

To qualify you must have a

• Bachelors degree in a health-related field.
• Five + years experience in clinical research and/or IRB regulatory work.
• Certified in Good Clinical Practice, Certified IRB Professional (CIP) or Certified IRB Manager (CIM) certification.
• Solid command of human subject regulations and policies. Must exercise a high degree of independent judgment and discretion relating to research issues.
• Superior organizational, analytical, time management, multi-tasking and interpersonal communication skills required.
• High degree of emotional intelligence.
• Excellent verbal and technical writing skills, proficient use of computer and relevant software and database applications (IRB Software, MS Word, PowerPoint, etc.)

PREFERRED QUALIFICATIONS:

Provide recommendations on study selection, audit scope and frequency, based on study population, study type, protocol, and other risk factors. Plan, conduct, and report internal quality improvement reviews, routine and for cause audits, to assure adherence to federal, state and local regulations and all NYUL human research policies, standard operating procedures. Provides advice, expert guidance and education to members of the NYUL HRP including IRB and research teams. Provide timely feedback through meetings with the research teams and IRB members and timely completion of the audit report and all audit related activities. Evaluate findings and prepare reports for the ADs review and sign off. 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 CAPA. Report all CAPA related completions and deficiencies (at a standard timepoint) to the AD and work with AD to present to the IRB. Provide support and assistance to NYUL researchers in the preparation and management of external audits and inspections by regulatory agencies and business partners. Based on an annual analysis, and working with the QIA team, develop and propose a QIA annual program for implementation including # and type of studies chosen for review. Complete reports QIA work for HRP leadership on status as compared to annual plan and prior years; including productivity metrics and aggregate results and findings. Develop training material and conduct training on the clinical research process and serve as a resource to NYUL research teams. Provide high-level guidance and assistance to researchers and IRB members and staff through education and training. Complete other tasks as assigned by the AD. Work on special projects related to QIA and HRP as needed. Periodically attend training necessary to retain and improve auditing and GCP knowledge/skills. Functions as a collegial and efficient partner to the research community. Attends HRP team meetings and other ad hoc meetings as needed and collaborates across divisions when necessary.

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 $73,770.80 - $83,500.00 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