NYU Langone Hospitals

Clinical Research Associate I

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Job Description

You are here: Home / Clinical Research Associate I Clinical Research Associate I 1137234_RR00099222 Research, NYU Grossman School of Medicine, Psychiatry-Psychedlic Med Prog (S2088) Full-Time/Regular NYU Grossman School of Medicine (SOM) Monday to Friday; 9:00AM – 5:00PM ABOUT NYU LANGONE HEALTH NYU Langone Health is a world-class, patient-centered, integrated academic medical center. Ranked as the 1 Hospital for quality and patient safety by Vizient, Inc., and with 10 clinical specialties among the top 10 in the nation according to U.S. News&World Report , NYU Langone’s culture is rooted in excellence in patient care, education, and research. Position Summary: We have an exciting opportunity to join our team as a Clinical Research Associate I. The Clinical Research Associate (CRA I) will report directly to the Research Project Manager (RPM) and the Center Director of the Center for Psychedelic Medicine and Principal Investigator (PI) of an NIH funded multi-center clinical trial for opioid use disorder and psychedelics. Job Responsibilities: Coordinating center activities Developing and executing the study's monitoring plans Development of educational materials for site coordinators and staff Providing regular updates to the PI and RPM regarding site start-up, recruitment, and enrollment status Assisting with providing annual updates to NIH, FDA, DSMB, and IRB regarding study progress Conducting site initiation, interim, and close-out visits Ensuring sites meet performance expectations related to recruitment, enrollment, and retention Reviewing site source documentation, case reports, and verifying accurate data capture Maintaining ongoing communications with site personnel and assisting with problem-solving during all stages of study start-up, conduct, and close-out Performing drug accountability reconciliation and destruction Verifying storage and shipment requirements are according to protocol Building and maintaining professional relationships with site personnel Analyzing issues and using sound judgment to make decisions and escalate study-related issues as necessary Traveling to clinical study sites as required including remote or onsite visits Maintaining the Master Regulatory File for the study Ensuring site regulatory files are current and verifying the timely submission of study documentation including safety reporting Reviewing yearly IRB approvals and any modifications in consent for each of the sites Ensuring that sites maintain the necessary state and federal approval to conduct clinical research with a Schedule 1 substance Participating in special projects and performing other duties as assigned Minimum Qualifications: To qualify you must have a Bachelor’s degree or equivalent, and a minimum of 4 years progressively responsible clinical research experience preferably in a research/academic/health care setting. Proficiency in using various Microsoft Office applications such as Word, Excel, Access, PowerPoint, and Outlook. Effective interpersonal and communication skills, both verbal and written. Ability to work within a team environment as well as independently. Ability to interface effectively with all levels of management; must work and communicate effectively with internal and external parties. Effective multi-tasker and problem solver; detail-oriented. Preferred Qualifications: CCRA certification, knowledge of basic medical terminology, experience working in an Academic Medical Center as a clinical monitor. Salary Range: The salary range for the role is $67,771.14 – $99,546.72 Annually. Actual salaries depend on a variety of factors, including experience, specialty, education, and hospital need. NYU Grossman School of Medicine is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. J-18808-Ljbffr