NYU Langone Medical Center, 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.NYULMC.org.
We have an exciting opportunity to join our team as a Research Regulatory Specialist for the Leon H. Charney Division of Cardiology, Department of Medicine.
In this role, the successful candidate This position will mainly focus on regulatory and compliance work. May be responsible for providing basic to moderate range of coordination for Research studies conducted at the Medical Center. Assists with recruitment, enrollment, research data collection and study coordination. Performs intra-operative monitoring and serves as liaison with the IRB and the internal and external funding agencies. Ensures accurate execution of research protocols in accordance with Good Clinical Practices, HIPAA and required obligations to patient/subject, Principal Investigator, research team and sponsor. Interfaces directly with patients/subjects and Principal Investigators in support of the clinical trials. Works under general supervision.
- Participates in special projects and performs other duties as required. Follows established SOPs/Guidelines in Cardiovascular Clinical Research Center.
- Budgets - Develop draft budgets and submit to the Principal Investigator. Assists in the preparation of funding reports to agencies. Works with Revenue Cycle when needed to identify procedures related to research.
- Reporting and Analysis Gathers and compiles data and assists in consolidating/analyzing data for presentation to sponsoring and regulatory agencies. Provides reports to all necessary parties (e.g., the principal investigator, sponsoring agency, etc.) on the progress of the study as needed. Formulates, prepares database and generates preliminary measurement reports for review by the PI.
- Continuous Learning: Position requires ongoing continuing education in all areas of research development. It is expected that the employee demonstrates proof of ongoing research education on a yearly basis. Training programs are provided through the SOM.
- Clinical Competency: Position requires competency in performing EKG, phlebotomy technique, centrifuge, handling, storing and shipping of specimens. Clinical training and didactic competency tests are required to perform basic procedures as part of position expectations. In house training and certification will be provided if needed. Other trainings and competencies required as needed.
- Recruitment - Screens potential patients/subjects for eligibility to the study and schedules the initial visits, includes: researching and gathering information from the medical record, physician referral, advertisement and directly scheduling a visit to evaluate the patient/subject. Reviews all the elements of the screening process with the Principal Investigator that include but not limited to: inclusion/exclusion criteria, completed informed consent, documentation of the event and the patient/subject willingness to participate in the study. Traveling to satellite sites for the purposes of screening and recruitment of patients/ subjects.
- Research Activities - Collects patient information for the research project(s) includes: abstraction of data from the patient chart (e.g., laboratory or diagnostic test results, surgical/radiation treatments delivered, adverse drug reactions, etc); abstraction of data for publications, or data collection from outside physicians offices. Uses tools to facilitate data collection (e.g. calendars, schedules, tracking logs, etc). Audits and updates the database or the case report forms. Conducts study visits, obtains and documents information within the time frame specified.
- Study Regulations - Knowledge of study regulatory status and keeps an up to date copy of regulatory documents. Assists with the informed consent process and ensure that the patient/subject fully understands what is required of them throughout the study. Follows through regularly with the patient/subjects and reminds them of visits and compliance.
- Human Subjects Research Updates and submits necessary documents required by the NYU Institutional Board (IRB), NYU Office of Clinical Trials and any other appropriate parties in order to obtain approval to conduct human subjects research. Secures accurate signatures and forwards documents and/or forms to appropriate destination. Prepare and submit monthly enrollment statistics to the Office of Clinical Trials and provide other information in a 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 1. Bachelors degree in life sciences, allied health or equivalent in a related discipline and Minimum of twoyears of progressively responsible project coordination experience, preferably in a research setting or an equivalent combination of education and experience. Medical background a plus due to the intricacies and complication of the studies in the program. 2. Effective oral, written, communication, interpersonal skills. 3. Must be able to work under the direction of supervision 4. Ability to operate research related equipment.5. Proficiency in using various Microsoft Office applications such as Word, Excel, and Outlook. Familiar with Internet applications.6. Ability to identify, analyze and solve problems.7. Time management skills and ability to work well under pressure.8. 2 years of prior experience with IRB research related work.
1. Knowledge of basic medical terminology is preferred.2. Prior experience working with Research Protocols.3. Experience working in an academic medical center environment4. Prior experience with audits and compliance research related work is preferred.
Qualified candidates must be able to effectively communicate with all levels of the organization.
NYU Langone Medical Center 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. And just as our employees invest so much in us, we invest in our employees. We're pleased to have one of the most competitive compensation packages not only among New York's hospitals and healthcare institutions, but within the corporate sector as well. We begin with exceptional medical, dental, and drug coverage. We enhance this basic coverage with comprehensive wellness programs, and supplement those with retirement investment and benefits plans, and generous paid time off allowances. Add to that a very attractive tuition program, and you'll see just some of the ways that NYU Langone Medical Center demonstrates our commitment to our employees.
NYU Langone Medical Center 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, sexual orientation, national origin, age, religion, creed, disability, military and veteran 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 Langone Medical Center'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.