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.
We have an exciting opportunity to join our team as a Program Manager, Resident Research.
In this role, the successful candidate works under the direct supervision of the Director of Research at NYU Langone Hospitals - Brooklyn. providing 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, providing guidance and support for department research coordinator(s), faculty, and staff at all affiliated study sites.
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
Assures compliance with FDA and OHRP guidelines for content and operation
Assists with the coordination of resident research education
Maintains and provides (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
Provides regulatory affairs support for all division of Dental Medicine projects
Oversees institutional review board submissions of all research projects and submits all necessary regulatory documents as required
Communicates with the Office of Science and Research (OSR) as required
Tracks all division of Dental Medicine research education requirements and certifications
Facilitates collection of Financial Disclosure Forms, CV's, and Medical Licenses as required
Collaborates with Director of Research and oversees protocol development, assisting with protocol review/design and editing of investigator initiated research protocols
Prepares and submits Investigational New Drug (IND) Application and Investigational Device Exemption (IDE) as required
Strategizes with division on possible research funding opportunities and feasibility of future projects
Participates in routine research audits for data quality, regulatory compliance, patient safety issues etc
Reports non-compliance and violations/deviations to institutional review board as required
Assures compliance at highest level with all federal regulations including ICH/GCP / FDA, OHRP, AHRQ, and NIH
Tracks enrollment and monitor research productivity, compliance, and oversight
Oversees development of research recruitments materials and advertisements as required
Creates, maintains, prepares and submits all necessary regulatory documents
Accountable for ensuring all amendments and annual renewals are submitted and approved within a timely manner
Performs remote data, on-site data and regulatory audits at affiliated sites as required
Collaborates with Hansjrg Wyss Department of Plastic Surgery Program Manager in aligning the division of Dental Medicine with department research goals and growth
Oversight and supervision of research office interns, assistants and coordinators; guidance to Clinical Research Coordinators
Cross-trains staff in research data management and regulatory affairs
Supervises personnel responsible for preparation IRB regulatory submissions and applications
Provides support for grant applications, renewals, and reports as required
Supervises and trains Clinical Research Associates, Assistants and Coordinators
Assigns projects to appropriate staff, including feasibility review of resident projects and faculty research (both investigator initiated, federally funded, and industry-sponsored)
Mentors junior staff members in the conduct of research and provide guidance in a constructive manner
Supervises the training/development and performance management for research staff
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, identifying all of the individual study coordinator time costs associated with a clinical trial, including evaluating standard of care procedures and research staffing needs
Graduate Degree (MPH or related field)
At least 4 years of experience in an academic research setting
Must have strong working knowledge of Human Subjects Protections regulations
Ability to interface effectively with all levels of management
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.
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.