NYU School of Medicine is one of the nation's top-ranked medical schools. For 175 years, NYU 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 School of Medicine at its core is committed to improving the human condition through medical education, scientific research, and direct patient care. For more information, go to med.nyu.edu, and interact with us on Facebook, Twitter and Instagram.
We have an exciting opportunity to join our team as a Research Project Manager.
The Research Project Manager will work independently to oversee various aspects of the study entitled Preventing Smoking Relapse after Total Joint Replacement Surgery pilot study, Principal Investigators, Scott Sherman, MD, MPH and Heather Gold, PhD. S/he will work with the study PIs to ensure that the project runs smoothly and according to the study timeline. The Project Manager will be responsible for ensuring that quality research standards are applied within the program in accordance with institutional policies. Requirements may include management of study team personnel, project and process execution, as well as regulatory and fiscal oversight of studies within the program. Performs operational monitoring of research activities across the program and recommends continuous quality improvement. S/he will develop all study materials, set up data collection systems, and oversee and manage all regulatory approval for the study. The Project Manager will serve as programmatic liaison with key stakeholders, including Orthopedic Surgery attending physicians. Ensures research protocols within the program are executed in accordance with Good Clinical Practice (GCP) standards, HIPAA and required obligations to participant, principal investigator, research team, institution and sponsor. Provides ongoing guidance and support to investigators and research staff to achieve quality outcomes. S/he will have direct contact with patient participants to recruit them into the study and conduct follow-up interviews. S/he will work autonomously and with limited oversight.
This position will be based at the NYU Translational Research Building but will require travel to the Hospital for Joint Diseases/Langone Orthopedic Hospital for participant recruitment. This position will be based at the NYU Translational Research Building but will require travel to the Hospital for Joint Diseases/Langone Orthopedic Hospital for participant recruitment.
Participates in special projects and performs other duties as required.
Financial/Programmatic - Supervises budget development and monitors expenditures providing fiscal oversight throughout individual studies within the program. Collaborates closely with IRB, OCT and SPA on study budgets, work orders and contractual agreements. Reviews sponsor-proposed budgets for adequate coverage and recommends changes as appropriate. May approve final budget together with investigator, administrator and/or study/project leader. May prepare funding and progress reports to sponsor agencies if applicable. May identify new potential sponsors/agents for trials as well as researches and participates in the development of protocols as assigned. May provide fiscal oversight of programs providing reports, justifications and reconciliation of accounts to department leadership and institutional offices.
Project Management - Responsible for the management and supervision of projects and personnel as assigned. Reviews progress of projects and initiates appropriate actions to achieve targeted objectives. Assigns and delegates tasks as appropriate to ensure on time and on budget project management.
Decision Making and Problems 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 and refers non solved issues and questions with recommendation to supervisor.Effectively interacting with investigators to communicate expectations for study timelines and milestones. Oversee communications with key stakeholders in the study, including Orthopedic Surgery attending physicians
Grants Assist with the preparation and submission of grant applications related to this area of research. May work with the administrator, investigator and institutional offices in grant related activities. Collects and organizes required paperwork for submission if applicable. Follow up and coordinates resolution of all issues progress.
Reporting and Analysis Researches, compiles and consolidates data and conducts preliminary analyzes to data collected for presentation to sponsor and regulatory agencies. Prepares reports to all necessary parties (e.g., the principal investigator, sponsor, etc.) on the progress of the study as needed. Formulates, prepares database and generates preliminary measurement reports for review by PI. May complete assessments on study subjects/patients following protocol (with proper training); continues to follow-through with items and patients as part of the research study.Recommends changes/additions to established data fields. May oversee staff assigned to this responsibility.
Continuous Learning - Position requires ongoing continuing education in all areas of research development (training programs are provided through the SOM). Promotes own professional growth and development in research role and maintains current expertise in area of practice. Maintains annual requirement of 10 CEUs in continuing research education; employee must demonstrate proof of ongoing research education. Serves as a resource to peers and works collaboratively with other disciplines within the area of expertise.
Recruitment Leads and evaluates the screening of potential patients/subjects for eligibility to the study at the Hospital for Joint Diseases/Langone Orthopedic Hospital. This may include gathering information from the medical record, physician referral, advertisement or directly scheduling a visit to evaluate the patient/subject. Reviews all the elements of the screening process with the Principal Investigators and lead study team personnel to monitor compliance with inclusion/exclusion criteria, completed informed consent process, and documentation of such.
Data Management Utilizing reports to track study progress and ensuring timeliness and quality expectations are met. Assist with data analysis and data management, in conjunction with study PIs. Responsible for developing data collection templates and working with MCIT to set up a data collection system. Responsible for collecting data from surveys at the time of recruitment and follow-up interviews with patient participants. Audits and manages data as it is entered into the database. Prepares forms and reports, compiles and analyzes data, statistics, and other materials for reports.
Study Regulations Develop all study materials, including patient recruitment materials, interview guides, and data collection templates. Aware of study regulatory status and keep an up to date copy of regulatory documents. Provides oversight and quality assurance of the informed consent process and ensures that the patient/subject fully understands what is required of them throughout the study. Follows through regularly with the patient/subjects reminding them of study tasks and compliance. May monitor any outward effects or issues regarding patient/subject safety and report this to the Principal Investigator. Work collaboratively with the two Principal Investigators to provide deliverables related to project activities.
Human Subjects Research As applicable, oversee all IRB NYU Institutional Board (IRB) applications, submit necessary documents required by the IRB, NYU Office of Clinical Trials and any other appropriate parties in order to obtain approval to conduct human subjects research (e.g., ensures the update and submission of necessary documents and/or forms to appropriate destination). Might prepare, audit and submit monthly enrollment statistics to the Office of Clinical Trials, and provides other information in timely manner, as necessary.
Demonstrates knowledge of the organizations Core Values and incorporates them into the performance of duties.
To qualify you must have a Master's Degree in a relevant field
4 years relevant experience working on health services research projects
Excellent communication skills (oral and written)
Deep interest in health-related research is essential
Basic database skills (Excel, Access, SQL)
Experience conducting research interviews in a health care setting
Must be proficient in Microsoft Office, specifically Word, Excel, and PowerPoint and have the ability to apply technology to resolve problems
The ideal candidate will have strong interpersonal and organization skills, outstanding judgment, initiative, and attention to detail
MPH Degree preferred
Knowledge of basic medical terminology is preferred.
Experience working in an Academic Medical Center preferred.
Familiarity with statistical (e.g. SPSS, STATA, R, SAS, etc.) and qualitative analysis software and ability to perform data analysis is desirable, but not required.
Strong writing skills, especially as required for IRB and other regulatory submissions
Qualified candidates must be able to effectively communicate with all levels of the organization.
NYU 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 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.
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.