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We have an exciting opportunity to join our team as a Research Coordinator.
In this role, the successful candidate The Greater New York Node (GNYN) of the NIDA Clinical Trials Network is an integral part of the Department of Psychiatry at New York Langone Health and the National Institute on Drug Abuse Clinical Trials Network (NIDA CTN). Our goals are to improve diagnosis and treatment of addictive disorders and to extend what is known about their root causes and physiology. Underlying the program is the conviction that clinical care, training and research are all enhanced where they coexist in a mutually supportive environment and that the quality of each component reflects the quality of the others.
The GNYN of the NIDA CTN is looking for a well-qualified Research Coordinator/Regulatory Specialist to join their growing team. The Research Coordinator will be responsible for maintaining the regulatory processes and submissions for NIDA CTN GNY studies and select studies within the Addiction Research Program. The Research Coordinator will work in close conjunction with GNYN and ARP staff, NYU Langone Health personnel, external IRBs, and other members of the NIDA CTN.
Manage regulatory requirements and critical documents for studies of the NIDA CTN GNY Node. Draft IRB and sponsor correspondence relating to regulatory, QA and DSMB issues and actions. Responsible for the submissions to both NYU Langone Healths IRB and external IRBs.
Serve as the regulatory point person to the participating sites of the NIDA CTN for external IRB submissions. Disseminate instructions to teams and troubleshoot, as needed.
Provides guidance and updates on regulatory requirements and IRB submissions to the project teams
Maintain appropriate ARP site and staff credentials. Responsible for alerting and notifying staff of impending expiration of various training or credentials.
Serve as main point person for compliance assessments, auditing and monitoring by outside agencies. Assist colleagues in preparation of such visits. Serve as a liaison with NYU Healths Human Research Regulatory Affairs.
Development and updating of organizational tools for the management and organization of regulatory binders.
Identify, respond to, and participate in the resolution of potential and actual problems in regulatory and QA activities. Provide necessary documentation in compliance with existing standard operating procedures, regulatory and/or data guidelines, etc.
Review and adapt existing SOPs, templates, and organizational systems as developed for the management of regulatory and quality assurance activities.
Maintain/enhance professional growth and development through participation in seminars, professional affiliations and internal training sessions to keep abreast of trends in the field of clinical research, addiction and project management.
Participate in special projects and performs other duties as assigned.
To qualify you must have a Bachelors degree or equivalent
Minimum of two years of progressively responsible project coordination experience, preferably in a research setting.
Effective multi-tasker and problem solver; detail oriented
Action-oriented and eager to embrace new opportunities and tough challenges with a sense of urgency, high energy, and enthusiasm
Ability to interface effectively with all levels of management; must work and communicate effectively with internal and external parties
Working knowledge of the Code of Federal Regulations, Good Clinical Practice, and Human Subjects Protection preferred
Exceptional organization skills and attention to detail
Proficiency in using various Microsoft Office applications including Word, Excel, PowerPoint, Outlook. Familiar with Internet applications
Effective interpersonal and communications skills (verbal and written)
Ability to work within a team environment as well as independently
Interest in and experience with addictions and/or clinical research is a plus.
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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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.