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Working independently and under general supervision, the Research Coordinator will support the Division of Pulmonary, Critical Care and Sleep Medicine in the administrative day-to-day project activities of clinical trials following good clinical practices, regulatory requirements, and sponsor standards to ensure compliance. The Research Coordinator will assist with on-boarding of clinical research staff to ensure clarity with regard to staff roles and responsibilities. In addition, the research coordinator will facilitate the transfer of clinical trials when new faculty is hired.
Study Start-Up; Clinical Trials, Translational, and Educational Research
Work independently with faculty members with IRB study set-up (NYU, Bellevue and CTSI study applications)
Review and process NDA, MTA, CDA and CTA via CRSU
Review and amend study budgets - work with division director, division administrator, grants manager, CTSI, study coordinators etc.
Communicate with CRSU, Pharmacy, and other departments involved to obtain appropriate quotes for study cost, obtaining CPT codes and identifying areas of the budget to be modified with the sponsor
Address all subsequent clarification requests from IRB, CRSU, and ERU and communicate to PI, Division Administrator, and study team as applicable
Review and prepare the ICF for Sponsor review and IRB submission review for consistency between CTA (specifically budget), protocol, consent, and other study documents
Conduct Site Evaluation and Initiation Visits with industry sponsors
Prepare and complete all appropriate regulatory documentation and correspond with industry contacts to ensure timely execution of study start-up
Attend sponsor Investigator Meetings if applicable
Develop protocol, consent, and other study documents for investigator initiated trials
Track/follow-up study progress, personnel changes, maintain CRMS subject database for enrolling trials
Submit IRB/CRMS/Bellevue/CTSI modifications
Work with study teams to create a study specific monitoring plan
Report RNIs to IRB and other entities if applicable
Work with PIs and investigators to create a plan to prevent adverse event from occurring again, if applicable
Complete annual renewals application for IRB/CRMS/Bellevue/CTSI
Work with study team to complete pre-audits, specifically before actual study audits
Review research invoices and route to appropriate personnel
Provide training to study personnel - PIs, co-investigators, study coordinators, and data managers
Collect, maintain and track training documentation of all study staff included on IRB related protocols
Perform quality assurance checks of consent forms and regulatory documentation on open protocols
Create electronic versions of consents
Maintain regular communication with industry sponsor, CRO, IRB, and institution
Identify and complete sponsor closure documents and long term storage location of study documents
Ensure appropriate closure with all regulatory authorities; IRB, FDA, etc.
Perform final payment reconciliation of all invoiceable items and follow-up with finance if necessary
Perform financial assessment of study - work with PI, CRSU, division director, division administrator, grants manager, etc.
Initiate various institutional applications (if applicable) including: IRB, CRMS, contracts and budgets, Bellevue (STAR), and CTSI
Provide training to study personnel - PIs, co-investigators, study coordinators, data managers, etc.
Arrange introductory meetings for the new PI and study team with applicable groups within the institution
Meet with PI regarding research plan and any unresolved items
Complete IRB/CRMS/Bellevue/CTSI notification - study closure or PI transfer applications
Complete all associated close-out regulatory documents
Arrange for transition of supplies to new location and complete associated documentation
To qualify you must have a Bachelor's Degree or equivalent in business administration, health care administration or related field.Minimum of two years of progressively responsible project coordination experience, preferably in a research setting.Proficiency in using various Microsoft Office applications such as World, Excel, Access, Power Point and Outlook Familiar with Internet applications. 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 customers. Ability to work within a team environment as well as independently. Commitment to continuous learning as required by department administration. Ability to operate research related equipment. Ability to work and make decisions independently. Time management skills and ability to multi task. Ability to identify, analyze and solve problems; ability to work well under pressure
Preferred Qualifications: Clinical Research Coordinator (CRC) Certification is preferred (required in some disciplines).Knowledge of basic medical terminology is preferred. Experience working in an Academic Medical Center Preferred
Qualified candidates must be able to effectively communicate with all levels of the organization.
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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. If you wish to view NYU 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. To view the Pay Transparency Notice, please click here.
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.