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We have an exciting opportunity to join our team as a Research Coordinator.
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 on 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
o Develop protocol, consent, and other study documents for investigator initiated trials
Oversee the regulatory maintenance for a large portfolio of over 30 research studies
Serve as the point person for all IRB-related study activities
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
Review all signed consent forms for completeness, confirm enrollment in CRMS, scan and file consent form, coordinate with study team to reconcile and document any discrepancies
o 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
Complete all associated close-out regulatory documents
Arrange for transition of supplies to new location and complete associated documentation
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
To qualify you must have a Bachelor's degree in life sciences, allied health or equivalent in a related discipline and 0-1 years experience or an equivalent combination of education and experience. Effective oral, written, communication, interpersonal skills. Must be able to work under the direction of supervision. Ability to operate research related equipment. Proficiency in using various Microsoft Office applications such as World, Excel, Access, Power Point and Outlook. Familiar with Internet applications. Ability to identify, analyze and solve problems. Time management skills and ability to work well under pressure.
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.
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. 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.
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Internal Number: 68101532
About NYU Langone Medical Center
NYU Langone Health is a world-class, patient-centered, integrated academic medical center, known for its excellence in clinical care, research, and education. Included in the 200+ locations throughout the New York area are five inpatient locations: Tisch Hospital, its flagship acute-care facility; Rusk Rehabilitation, ranked as one of the top 10 rehabilitation programs in the country; NYU Langone Orthopedic Hospital, a dedicated inpatient orthopedic hospital with all musculoskeletal specialties ranked top 10 in the country; Hassenfeld Children's Hospital at NYU Langone, a comprehensive pediatric hospital supporting a full array of children's health services; and NYU Langone Hospital—Brooklyn, a full-service teaching hospital and level 1 trauma center located in Sunset Park, Brooklyn. Also part of NYU Langone Health is the Laura and Isaac Perlmutter Cancer Center, a National Cancer Institute–designated cancer center, and NYU School of Medicine, which since 1841 has trained thousands of physicians and scientists who have helped to shape the course of medical history.