Description
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. At NYU Langone Health, equity, diversity, and inclusion are fundamental values. We strive to be a place where our exceptionally talented faculty, staff, and students of all identities can thrive. We embrace diversity, inclusion, and individual skills, ideas, and knowledge. For more information, go to, and interact with us onLinkedIn,Glassdoor,Indeed,Facebook,TwitterandInstagram.
Position Summary:
We have an exciting opportunity to join our team as a Research Regulatory Specialist.
Serve as liaison between research sponsors, CRO, IRB and internal departments or staff to ensure compliance and management with study requirement and initiatives. Ensures the accurate execution of research protocols in accordance with Good Clinical Practices, HIPAA and required obligations to patient/subject, Principal Investigator, research team and the sponsor. Partners with respective internal and external teams as needed; Interfaces directly with patients/subjectsand the Principal Investigator in support of the clinical trials if applicable. Provides guidance to Research support staff.
Works autonomously and with limited oversight.
Job Responsibilities
- Financial/Protocol Development Develops draft budget, monitors budget throughout trial and recommends staffing levels based on reviewed protocol. Reviews sponsor-proposed budget for adequate coverage and recommends changes as appropriate. Develops draft and final budgets together with study/project leader. Preparation of funding reports to funding agencies. Might identify new potential sponsors/agents for trials and researches and participate in the development of protocols as assigned.
- NYU Office of Clinical Trials/IRB If applicable, oversee the submission of necessary documents required by the NYU Institutional Board (IRB), NYU Office of Clinical Trials in order to obtain approval to conduct human subjects research. Secures accurate signatures and forwards documents and/or forms to appropriate destination. Ensures the accurate execution of research protocols in accordance with Good Clinical Practices, HIPAA and required obligations to patient/subject, Principal Investigator, research team and the sponsor. Monitors any outward effects or issues regarding patient/subject safety and reports this to the appropriate party. Might oversee the monthly enrollment statistics submission to the Office of Clinical Trials, and provides other information in timely manner, as necessary.
- Reporting and Data Analysis Prepares progress reports to funding agencies and presentations to sponsoring and regulatory agencies. Prepares and provides reports to all necessary parties (e. g., the principal investigator, sponsoring agency, etc.) on the progress of the study as needed. Recommends changes/additions to established data fields. Analyses data collected, formulates, prepares database and generates a complete measurement report for review by the director. May oversee staff assigned to this responsibility.
- Study Regulations - Aware of study regulatory status and keep an up to date copy of regulatory documen
Compensation Information:
$0.0 / - $0.0 /
Starting At: 0.0
Up To: 0.0
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