NYU GROSSMAN SCHOOL OF MEDICINE is one of the nation's top-ranked medical schools. For 175 years, NYU Grossman 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 Grossman 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 LinkedIn , Glassdoor , Indeed , Facebook , Twitter and Instagram . POSITION SUMMARY: We have an exciting opportunity to join our team as a Program Supervisor - Education & Quality Assurance, Clinical Trials Office. The Program Supervisor for Safety, Compliance and Education is responsible for overseeing the internal auditing and educational activities in the Clinical Trials Office, for all cancer-related clinical trials conducted on the NYU Langone Health campus, at network locations in Brooklyn and Long Island, and affiliate locations at Bellevue Hospital and the VA (Veterans Administration). In addition, this position will manage a student rotation program in collaboration with the NYU Office of Science and Research (OSR) that is recommended for all cancer-focused clinical research staff members on the NYU campus. The supervisor will have oversight of 1-3 FTEs. JOB RESPONSIBILITIES: * Create and implement a standard orientation program for all clinical research staff and faculty from any Department managing cancer-related trials on the NYU Langone campus. This program should orient new staff and faculty to the structure of the Cancer Clinical Trials office and provide an overview of the offices operations. This position will work with the CTO medical director for all faculty orientation processes and needs. * Create and implement a standard educational program for all incoming staff and ensure they adhere to the program utilizing educational modules in the FOCUS system. * Implement additional educational modules or require retraining when needed as part of corrective action plans. * Run a monthly Cancer Clinical Trials Office education series. Responsible for communications and education associated with new NYULH and/or PCC regulations, policies and guidance that affect the conduct of clinical trials. * Supervise staff responsible for FDA submissions, including IND safety reports, for Investigator-Initiated trials where NYU holds the IND. Supervise staff related to education. Hiring, training and oversight of direct reports. * Oversee internal audits and reports results to principal investigators, assists study teams with implementation of corrective and preventative action plans. Provide reports of frequent findings to CTO leadership. May interface with the Institutional Review Board (IRB) when deviations or protocol violations are identified and meet requirements for reporting to the IRB. Implement education programs surrounding these areas. * Responsible for audit preparation activities preceding all external inspections, including government inspections by the Food and Drug Administration (FDA), cooperative group and sponsor audits. Serves as primary contact, coordinator and liaison for these audits. * Ensure audit findings are clearly communicated to PIs and that formal responses are submitted in a timely manner. Reviews Correction and Preventative Action (CAPA) prior to submission. * Reviews the CTO protocol deviations databases monthly and perform route cause analysis (RCA) for all protocol violations. Present to leadership semi-annually. * Lead and implement special projects and strategic initiatives to improve compliance and/or enhance clinical trials office operations based on findings from internal audits and routine monitoring visits of cancer related clinical trials. * Performs all other duties as assigned. MINIMUM QUALIFICATIONS: To qualify you must have a Bachelors Degree, preferably in business administration or in the life sciences. At least 6 years of experience in oncology clinical research operations including regulatory and data management experience. 3 years of experience in Quality Assurance. Full understanding of clinical research data management functions; Understanding of federal regulations governing the conduct of clinical trials. Proficiency in using various Microsoft Office applications such as Word, Excel, Access, Power point and Outlook. Effective oral and written communication skills, interpersonal skills, and organizational skills. Ability to interface effectively with all levels of management and faculty and must work and communicate effectively with both internal and external customers. Ability to work within a team environment as well as independently. Time management skills and ability to work well under pressure. Ability to multi task and manage multiple projects with deadlines. PREFERRED QUALIFICATIONS: Masters degree in business management or life sciences. 8 years of experience with oncology clinical research auditing and implementation of corrective action plans; experience with FDA audits. Qualified candidates must be able to effectively communicate with all levels of the organization. NYU Grossman 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 Grossman 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 Grossman School of Medicine's EEO policies, please click here. Please click here to view the Federal "EEO is the law" poster or visit for more information. 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