Family Health Centers at NYU Langone, a designated Level 3 Medical Home, is the largest federally qualified health center network in New York State, and the second largest in the nation. It includes nine primary care sites, 33 school-based health centers and dental clinics, four day care centers, the nation's largest dental residency program, and New York State's largest behavioral health program. The network also includes 12 community medicine sites providing care to disenfranchised New Yorkers, comprehensive HIV services, chemical dependency programs, and a family support center that offers educational, vocational, and other social support programs. Learn more about Family Health Centers at NYU Langone.
Position Summary: We have an exciting opportunity to join our team as a Program Manager.
In this role, the successful candidate This individual works under the direct supervision of the Director of Research at NYU Langone Hospitals - Brooklyn. Provide central oversight of all division of Dental Medicine research. Strict adherence to timelines and deadlines is mandatory. This position serves as the main point of contact for dental residency research and all affiliated sites. This individual will serve as the Director's second in command and first point of contact for day to day flow of clinical research activity. Provide guidance and support for department research coordinator(s), faculty, and staff at all affiliated study sites. Qualified candidates must be able to effectively communicate with all levels of the organization
-Provides support for Director of Research at NYU Langone Hospitals - Brooklyn. Involved in high level decision making with Director for the division including protocol review, editing, study design, study feasibility, and business development. This individual supervises and trains Clinical Research Associates, Assistants and Coordinators. Responsible for assigning projects to appropriate staff. This includes: feasibility review of resident projects and faculty research (both investigator initiated, federally funded, and industry-sponsored). Mentor junior staff members in the conduct of research and provide guidance in a constructive manner. It is the responsibility of the Program Manager to assure compliance with FDA and OHRP guidelines for content and operation. Assists with the coordination of resident research education.
Maintain and provide upon request research status reports for Principal Investigators, department leadership, clinical teams, and institutional review board. Accountable for accuracy of research information in clinical trial management system. Provide regulatory affairs support for all division of Dental Medicine projects. Oversee institutional review board submissions of all research projects. Submit all necessary regulatory documents as required. Communicate with the Office of Science and Research (OSR) as required.
Track all division of Dental Medicine research education requirements and certifications. Facilitate collection of Financial Disclosure Forms, CV's, and Medical Licenses as required. Collaborate with Director of Research and oversee the following initiatives: protocol development: assistance with protocol review / design and editing of investigator initiated research protocols. Prepare and submit Investigational New Drug (IND) Application and Investigational Device Exemption (IDE) as required. Strategize with division on possible research funding opportunities and feasibility of future projects
Supervise the training/development and performance management for research staff. Provide -Staff Management: Oversight and supervision of research office interns, assistants and coordinators. guidance to Clinical Research Coordinators. Cross-train staff in research data management and regulatory affairs. Supervise personnel responsible for preparation IRB regulatory submissions and applications. Provide support for grant applications, renewals, and reports as required.
-Budgetary oversight: Responsible for development and feasibility review of budgets for industry-sponsored, investigator- initiated studies, and any resident project which requires division funds to conduct research. Performs clinical cost analysis -identifies all of the individual study coordinator time costs associated with a clinical trial, including evaluating standard of care procedures and research staffing needs
-Participate in routine research audits for data quality, regulatory compliance, patient safety issues etc. Report non-compliance and violations/deviations to institutional review board as required.
- Assure compliance at highest level with all federal regulations including ICH/GCP / FDA, OHRP, AHRQ, and NIH. Track enrollment and monitor research productivity, compliance, and oversight. Prepare and submit all necessary regulatory documents as required
-Oversee development of research recruitments materials and advertisements as required. Create and maintain all regulatory documents. Accountable for ensuring all amendments and annual renewals are submitted and approved within a timely manner. Perform remote or on-site data and regulatory audits at affiliated sites as required.
-Collaborate with Hansjrg Wyss Department of Plastic Surgery Program Manager in aligning the division of Dental Medicine with department research goals and growth.
Minimum Qualifications: To qualify you must have a -Must have at least 4 years of experience in an academic research setting -Graduate Degree required (MPH or related field) -Must have strong working knowledge of Human Subjects Protections regulations -Effective oral, written, communication, interpersonal skills. Ability to interface effectively with all levels of management and must work and communicate effectively with both internal and external departments and organizations -Ability to work within a team environment as well as independently -Biostatistics, epidemiology, and clinical study design experience preferred
Qualified candidates must be able to effectively communicate with all levels of the organization.
Family Health Centers at NYU Langone network 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. Family Health Centers at NYU Langone 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.
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.