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.
Position Summary: We have an exciting opportunity to join our team as a Research Coordinator.
In this role, the successful candidate will work as part of a team to initiate and manage research studies in the most optimal fashion. Ensure the accurate execution of research protocols in accordance with Good Clinical Practices, HIPPA and required obligations to patient/subject, Principal Investigator, research team and the sponsor. Directly interface with the Principal Investigator, research team and sponsor in support of the clinical trials. Establish liaisons with School of Medicine, and NYU Medical Center that may include: Research Nurses, Research Pharmacists, Program Managers, Clinical Information Systems, Regulatory staff.
Reporting: Compile data and assist in consolidating/analyzing data for presentation to sponsoring and regulatory agencies. Provide reports to all necessary parties (e.g., the principal investigator, sponsoring agency, etc.) on the progress of the study as needed. Recommend changes/additions to established data fields.
Development: affiliations and internal training sessions to keep abreast of trends in the field of clinical research.
Professional: Maintain/enhance professional growth/development through participation in seminars, professional
Teamwork: Cooperate with clinical staff, administration, other SOM and medical center staff members.
Problem Resolution/Prioritization: Identify, respond to and participate in the resolution of potential and actual problems in conducting studies, using a multi-disciplinary approach.
Communication: Clear and concise oral and written communication with research and clinical staff, patients, representatives from sponsors and other medical center staff.
Data Collection/Abstraction/Entry: Utilize the appropriate methodologies to collect patient information for the research project(s). This may include 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. Use tools to facilitate data collection (e.g. calendars, schedules, tracking logs, etc). Enter data into the database or case report forms ensuring data entered is correct and consistent with the source document.
Protocol Compliance: Ensure that standard steps regarding patient registration, eligibility criteria, follow-up, and required documentation is consistently followed.
May be required to travel to study initiation (that is, where sponsor teaches protocol to PI and CRC).
May complete assessments on study subjects/patients per protocol (with proper training); continue to follow-through with items and patients as part of research study.
Employee must also complete 'Standard Precautions' and required IRB tutorial
Environmental training is provided for the proper handling and collection of biological substances and the packaging and shipment of samples.
Collect, prepare, ship, and/or store biological materials using universal precautions.
Maintains files in an organized and up-to-date manner in order to facilitate their retrieval and maintains copies of all required on-going documentation and forms for the files.
Secure accurate signatures and forward documents and/or forms to appropriate destination.
Report adverse events and serious adverse events to applicable agencies
Respond to requests in a timely manner, give/receive correct information, encourage required dialogue/follow-through.
Record, update, edit and maintain confidential information onto paperwork or web-based forms in a neat, accurate and timely manner and ensure subsequent data collection as required.
Maintain complete, accurate subject charts, case report forms, enrollment logs, and hospital records from patient screening through final follow-up.
Timely correction of queries stemming from inappropriately reported and or recorded data, initiate prompt data edits for all subsequent questions.
Monitor any outward effects or issues regarding patient/subject safety and report this to the Principal Investigator, Physician and Research Nurse.
Conduct monitoring visits
Utilize available resources and established procedures to identify problems for quick resolution.
Demonstrate knowledge of policies and procedures of the host institution where the study is being conducted and the regulatory requirements such as IRB and other approvals if necessary.
Collaborate with various personnel that may be involved in assisting with specific aspects in the study.
Review all the elements of the screening process with the Principal Investigator that being: inclusion/exclusion criteria, completed informed consent, documentation of the event and the patient/subject willingness to participate in the study.
Registering/randomizing patient/subject according to protocol and internal policies.
Reviewing patient/subject medical history and screening procedures for eligibility to the study.
Thorough knowledge of research study, study rationale, study subject, and clinical procedures associated with the study.
Minimum Qualifications: To qualify you must have a Bachelor's degree plus one to two years related experience or equivalent combination of education and experience. Clinical Research Coordinator (CRC) Certification is preferred. Excellent interpersonal, writing and verbal communication skills. Must be able to work and make decisions independently. Must be able to use PC for analysis and correspondence.
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 or 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 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.