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Position Summary: We have an exciting opportunity to join our team as a Clinical Research Coordinator.
The Clinical Research Coordinator (CRC) is responsible for the coordination and administration of clinical trials in the Center for Clinical Research in the Department of Orthopaedics at NYU Langone Medical Center, Hospital for Joint Diseases. The CRC will develop, implement, and coordinate research and administrative procedures for the successful management of clinical trials. The CRC will perform diverse administrative duties requiring analysis, sound judgment, and a high level of knowledge of study specific protocols.
Administratively and clinically manage an average of six to eight clinical trials
Adhere to Research and Departmental SOPs
Adhere to Good Clinical Practices and the study protocols
Ensure scientific integrity of data and protect the rights, safety, and well-being of patients enrolled in clinical trials
Discuss study protocols with patients and verify the informed consent documentation
Provide patient with written communication of their participation (i.e. copy of the signed informed consent)
Ensure patient's referring physician receives notification of patient's participation in studies as requested by the patient
Meet with patient for each visit and maintain accessibility to discuss any questions/concerns regarding the study
Collect, process, and ship blood/urine specimens at scheduled patient visits
Schedule all patient research visits and procedures consistent with protocol requirements
Complete and maintain case report forms per FDA guidelines, and review them against the patient's medical record for completeness and accuracy
Administer questionnaires/diaries per protocol
Ensure that non-serious and serious adverse events are properly documented and reported Screen all laboratory results when received and follow protocol procedure regarding abnormal results Ensure all laboratory results are given to appropriate doctors for review of clinical significance, then file results in the patient study binder Ensure the filing and maintenance of all regulatory documents Schedule monitor visits and set up for monitoring visits prior to monitors arrival Other duties as assigned.
Screen all laboratory results when received and follow protocol procedure regarding abnormal results
Ensure all laboratory results are given to appropriate doctors for review of clinical significance, then file results in the patient study binder
Collecting patient information for the research project which includes abstraction of data from patient charts (e.g., laboratory or diagnostic test results, surgical treatments delivered, adverse drug reactions, etc)
Gathers and compiles data and assists in consolidating/analyzing data for presentation to sponsoring and regulatory agencies
Screens potential patients/subjects for eligibility to the study and schedules the initial visits. This includes researching and gathering information from the medical record and/or physician referral.
Track and report on progress of study including site patient enrollment
Review key study quality metrics for new trials (trial feasibility and eligibility) and determine appropriate action in conjunction with principal investigators
Investigate queries and monitor discrepancies on clinical trials
Manage the preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents
Oversees the data management of clinical trials including database development, data review and cleaning and that final database deliverables are in compliance with regulatory agency guidelines
Demonstrates advanced proficiency with RedCap Database
Other duties as assigned
To qualify you must have a Bachelors degree
Minimum two years of experience in a related healthcare position
Previous experience with clinical trials
Able to read, analyze, and interpret information from professional journals, technical procedures, or governmental regulations
Able to effectively present information and respond to questions from physicians, staff and patients
Knowledge of Good Clinical Practices and the regulations necessary for the protection of human subjects and the conduct of clinical research required
Knowledge of EMR system
Able to function effectively in a team setting
Needs to demonstrate consistent professional conduct and meticulous attention to detail.
Must possess excellent verbal and written communication skills as well as excellent interpersonal skills with patients, staff, and other health care professionals
Required to sit for CCRC after 2 years
Travel to any of the other NYU Langone Medical Center locations may be necessary upon request
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.