Program Manager

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.

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Position Summary:

We have an exciting opportunity to join our team as a Program Manager.

The position will supervise the Heart Failure Clinical Research Program consisting of research coordinators and program/project assistants. Responsible for initiating, overseeing the conduct, progression, compliance, management of research studies within the Division of Cardiology, Prevention Center, providing moderate to advanced coordinating. Monitors study timelines and ensure timely implementation of work plans. Submits IRB applications and monitors approval and addendum processes. Works with the Assistant Director of Cardiology Clinical Research to develop study budgets and to ensure billing compliance.

Assists in the day-to-day supervision and motivates the research team to sustain highly productive and professional activities. Ensures the accurate execution of research protocols in accordance with Good Clinical Practices, HIPAA and required obligations to patient/subject, Principal Investigator (PI), research team and the various sponsors. If applicable, may interface directly with patients/subjects and the Principal Investigator(s) in support of the clinical trials.

Provides guidance to research support staff. Works autonomously and with limited oversight. Works with Division leadership to regularly report metrics on study status. Performs intra-operative monitoring and serves as liaison with internal and external funding agencies, sponsors, and CRAs.

Job Responsibilities:

• Demonstrates knowledge of the organizations Core Values and incorporates them into the performance of duties.
• Assists the Assistant Director in recruiting, hiring, training, and completion of employee performance reviews. PM will supervise research coordinators, project assistants, and volunteers for the program and ensures all office policies and procedures are being implemented.
• Financial/Protocol Development:
  Develops draft budgets, monitors budget throughout trial and recommends staffing levels based on reviewed protocol under the guidance of the Assistant Director. 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.
  
  Consistently makes sure study team is entering visits into the CRMS system as well as invoicing for other identifiable items in a timely manner.
• Regulatory
  - Oversees the submission of necessary documents required by the NYU Institutional Board (IRB), Bellevue Hospital, NYU Office of Clinical Trials, and Central IRBs (when applicable) 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. Oversees the monthly enrollment statistics submission to the Assistant Director, PIs, 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 (if applicable). Prepares and provides reports to all necessary parties (e.g., the principal investigator, sponsoring…