NYU Langone Health is a world-class, patient-centered, integrated academic medical center, known for its excellence in clinical care, research, and education. It comprises more than 200 locations throughout the New York area, including five inpatient locations, a children’s hospital, three emergency rooms and a level 1 trauma center. Also part of NYU Langone Health is the Laura and Isaac Perlmutter Cancer Center, a National Cancer Institute designated cancer center, and NYU School of Medicine, which since 1841 has trained thousands of physicians and scientists who have helped to shape the course of medical history. For more information, go to nyulangone.org, and interact with us on Facebook, Twitter, YouTube and Instagram.
We have an exciting opportunity to join our team as a Director-Research Integrity and Compliance.
In this role, the successful candidate helps to ensure that biomedical research at NYU Langone Health (NYU Langone) is conducted in accordance with applicable legal, regulatory and contractual obligations and with NYU Langone’s institutional policies. The Director will administer multiple activities associated with research compliance and integrity in order to enhance the research mission of NYU Langone. The Director works closely with faculty, academic departments, the Office of Science & Research, Research Finance, and the Office of General Counsel to carry out his/her duties.
- Manages a compliance program covering the conduct of biomedical research at NYU Langone and applicable laws, regulations and guidelines related to grant administration, sponsored program management, human subjects protection and IRB, clinical trials, clinical research billing, FDA rules and regulations, animal welfare and IACUC, biosafety, select agents, export controls, controlled substances, conflicts of interest, research integrity and scientific misconduct, intellectual property, data management, acquisition & sharing, and data privacy & security.
- Oversees NYU Langone’s efforts to comply with the requirements of all sponsors of NYU Langone research, including the requirements of the NIH, other government-funded research, industry and private sponsors.
- Coordinate with Office of General Counsel, Internal Audit, Office of Science & Research and other areas to effectively manage the research compliance function.
- Develop reporting on key indicators related to research compliance and integrity.
- Serve as Research Integrity Officer for the Organization. Foster an environment that promotes the responsible conduct of research and deals promptly with allegations or evidence of possible research misconduct; complies with the requirements of 42 CFR Part 93, notifies the Office of Research Integrity (ORI) when applicable, sequesters evidence, advises the research misconduct committee, drafts and/or reviews inquiry and investigation reports.
- Conduct, in collaboration with key stakeholders in the NYU Langone research community, an annual risk assessment to identify, mitigate and address the areas of greatest potential risk of research activities.
- Utilizing the results of the risk assessment, develop an annual workplan to address key risk areas.
- Work with key stakeholders to ensure that NYU Langone policies and procedures associated with the conduct of NYU Langone research comply with applicable legal and regulatory requirement, identify the need for new policies, and work with appropriate parties to address new policies and policies updates.
- Advises staff and management on the implications of proposed and existing regulations, policies, and practices governing research compliance
- Chair the Research Compliance Oversight Committee.
- Develop and implement ad hoc and formal communication and training programs.
- Work with Internal Audit, Office of General Counsel, regulatory authorities and others as appropriate to conduct or advise on investigations and/or audits internally or externally identified, including inquiries alleging scientific misconduct, fraud or other non-compliance with legal, regulatory or contractual obligations; and
- Performs other related duties as assigned.
To qualify you must have a Bachelor’s degree
Minimum of 5 years experience addressing research compliance and in applying regulations related to sponsored research for an academic medical center, or the equivalent experience in a related area of hospital or research administration
Strong academic background
Proven excellent analytical, oral and written communication (including presentation), advising and project management skills
Demonstrated judgment and discretion
Ability to understand, apply, and communicate complicated policies and laws and regulations at all levels within NYU Langone while maintaining high level of confidentiality
Ability to work independently and to make decisions on projects without additional oversight
Ability to successfully collaborate with individuals at various levels throughout NYU Langone to elicit needed information, discuss sensitive information, and develop workable solutions to meet applicable policies and protect NYU Langone and its research mission.
Ability to work closely with General Counsel, other members of the Office of General Counsel, and other members of senior NYU Langone and departmental leadership.
Demonstrated ability to achieve results in a fast paced, deadline driven environment with multiple priorities and stakeholders
Master’s degree or JD
Ten years experience addressing research compliance and in applying regulations related to sponsored research for an academic medical center, university or the equivalent experience in a related area of hospital or research administration
Experience with Research Misconduct
Qualified candidates must be able to effectively communicate with all levels of the organization.
NYU Langone Health 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 Langone Health 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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