Research Regulatory Specialist

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. At NYU Langone Health, equity, diversity, and inclusion are fundamental values. We strive to be a place where our exceptionally talented faculty, staff, and students of all identities can thrive. We embrace diversity, inclusion, and individual skills, ideas, and knowledge. For more information, go tomed.nyu.edu, and interact with us onLinkedIn,Glassdoor,Indeed,Facebook,TwitterandInstagram.

Position Summary:

We have an exciting opportunity to join our team as a Research Regulatory Specialist. In this role, the successful individual will work closely with Dr. Leonardo Trasande and his research team on projects and to improve the quality and efficiency of human subject research protocol submissions and investigators' responses to IRB regulatory reviews relating to the impact that environmental hazards have on children's health in the Division of Environmental Pediatrics. An integral member of the research team and in compliance with all regulatory institutional and departmental requirements, the Research Regulatory Specialist will be responsible for regulatory maintenance support of clinical studies. Your specific responsibilities will include overseeing clinical study regulatory responsibilities. You will serve as a liaison between the IRB and the research team. The Research Regulatory Specialist will facilitate the preparation of protocols to be compliant with IRB standards. In addition, the Research Regulatory Specialist will provide support to investigators in responding effectively to IRB regulatory review comments, through explanation of such comments and assistance in providing appropriate responses and/or implementing requested changes. This individual will be instrumental in developing and implementing materials for researchers and provide instruction on how to prepare, review, and process protocols for single and multi-site studies. Serve as liaison between research sponsors, CRO, IRB, and internal departments or staff to ensure compliance and management with study requirements and initiatives. Ensure the accurate execution of research protocols in accordance with Good Clinical Practices, HIPAA, and required obligations to patient/subject, Principal Investigator, research team, and the sponsor. Partners with respective internal and external teams as needed. Interfaces directly with patients/subjects and the Principal Investigator in support of the clinical trials if applicable. Provides guidance to research support staff. Works autonomously and with limited oversight.

Job Responsibilities:

• Serve as a link and liaison between the IRB central office and the Division of Environmental Pediatrics in tracking and facilitating IRB submissions.
• Serve as a link and liaison for CRMS, Research Navigator, and any other NYU Langone online tools for studies and grants management.
• Conduct submissions to the IRBs, including new protocols, continuing reviews, modifications, and reports of unanticipated problems. Conduct submissions to the IRB, sponsor, or other regulatory agencies.
• Obtain signatures on regulatory documents, filing study documents, processing personnel changes, revising regulatory documents, and maintaining study binders/electronic folders.
• Obtain continuing approvals from various committees and organizations (which can include Scientific Committee, Institutional Review Board, Biosafety Committee, and Radiation Committee).
• Maintaining knowledge of Good Clinical Practice (GCP), clinical research activities and guidelines related to consent, ethical conduct and protection of human subjects, and federal, local, and institutional regulations.
• Oversee and maintain clinical trial regulatory documents with minimal supervision, including: filing study documents, obtaining signatures, processing personnel changes, revising regulatory documents, and maintaining study binders/electronic folders.
• Oversee monitoring visits with sponsor and/or CRO's site initiation visits, and study closeouts.
• Assist with study start-up activities, including but not limited to: CTSI, CRSU, Institutional Review Board, Radiation Committee, Safety Committees, Investigational Pharmacy, etc.
• Assist with IND Safety Report reviews, submissions, and reporting.
• Follow up and coordinate resolution of all issues and resolves processing problems, escalating to the PI as applicable.
• Assist with reporting on study-related deliverables, progress reporting, etc.
• Oversee planning/management of study activities and of multiple projects as assigned.
• Might identify new potential sponsors/agents for trials and researchers and participate in the development of protocols, as assigned.
• Review all the elements of the screening process with the Principal Investigator, including: inclusion/exclusion criteria, completed informed consent, documentation of the event and the patient/subject willingness to participate in the study.
• Decision making and problem solving: Combines and evaluates information and data to make decisions about relative importance of information and choosing the best solution to solve problems. Resolves complex situations based on established policies and procedures and refers non-solved issues and questions to the supervisor.
• Provides guidance, training, and leadership to staff. May have input into staff evaluations.
• Participates in special projects and performs other duties as required.

Minimum Qualifications:

To qualify you must have a Bachelor's degree or equivalent in business administration, healthcare administration, or related discipline. Minimum of four years of progressively responsible related research regulatory experience on clinical/research trials studies. Proficiency in using various Microsoft Office applications, such as Word, Excel, Access, Power Point, and Outlook. Familiar with internet applications. Effective oral, written, communication, and interpersonal skills. Ability to interface effectively with all levels of management and must work and communicate effectively with both internal and external customers. Ability to work within a team environment as well as independently. Ability to work and make decisions independently. Time-management skills and ability to multitask. Strong understanding and knowledge base of coordination requirements associated with clinical/research trials. Ability to identify, analyze, and solve problems. Ability to work well under pressure.

Preferred Qualifications:

Clinical Research Coordinator (CRC) Certification preferred (required in some disciplines). Knowledge of basic medical terminology is preferred.

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.

NYU Langone Health provides a salary range to comply with the New York state Law on Salary Transparency in Job Advertisements. The salary range for the role is $62,400.00 - $75,000.00 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.

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