Research Project Manager

NYU Langone Health•New York, NY
•$121,792 - $156,000

About The Position

The Research Project Manager for xenotransplant supports the Transplant Institute by managing the development, implementation, and success of living and brain-dead decedent xenotransplant initiatives. The role provides advanced coordination of projects, including recruitment, enrollment, research data collection, study coordination, grant submissions, study monitoring, and liaison activities with internal and external funding agencies. The position ensures accurate execution of research protocols in accordance with Good Clinical Practices, HIPPA, and obligations to patients or subjects, the Principal Investigator, the research team, and sponsors. It may involve direct interaction with patients or subjects and the PI, coordination with Medical Center stakeholders, support for research study initiation and management, and placing clinical-trial-related orders for an appropriate provider to pend. The role works under general direction. The position supports project administration, study regulatory compliance, data management, human subject and decedent research oversight, reporting and analysis, grant activity, budgeting, decision-making, and communication across the Medical Center. Laboratory-related duties may include specimen centrifuging, handling, storage, and shipping. Training and certification are provided for applicable procedures. Ongoing research education is required, including 10 continuing education units annually. The role may provide students with technical guidance on sample preparation techniques, extraction lines, equipment, laboratory practices, and safety protocols. It is also expected to ensure timely and accurate completion of research projects, demonstrate the organization's Core Values, and participate in special projects and other required duties.

Requirements

  • Master's degree.
  • Ability to effectively communicate with all levels of the organization.
  • Maintain annual completion of 10 continuing education units in research education and demonstrate proof of ongoing research education.

Nice To Haves

  • Master's degree in business administration, health care administration, pharmacy, or a related field.
  • Experience with transplant and/or research operations.

Responsibilities

  • Manage the development, implementation, coordination, and success of living and brain-dead decedent xenotransplant initiatives.
  • Support recruitment, enrollment, research data collection, study coordination, study monitoring, and grant submissions.
  • Ensure research protocols are accurately executed in accordance with Good Clinical Practices, HIPPA, and obligations to patients or subjects, the Principal Investigator, research team, and sponsor.
  • Liaise with internal and external funding agencies and relevant Medical Center stakeholders, including research coordinators, research pharmacists, program managers, medical technicians, Clinical Information Systems, and Regulatory Services.
  • Assemble and maintain project plans and progress documentation using standardized project management tools and NYU Langone Health guidelines.
  • Assist with development and execution of Transplant Institute goals and objectives and development of new programs and projects.
  • Build constructive stakeholder relationships; identify routine problems and recommend solutions; organize, prioritize, and expedite departmental workflows.
  • Prepare presentations, analyses, and process-improvement recommendations; gather and update data for reports and databases; perform ad hoc data analysis for project planning.
  • Facilitate project team meetings, including setting agendas and objectives, recording decisions, and following up on action items; track milestones, owners, and target completion dates.
  • Monitor study regulatory status and maintain current copies of regulatory documents.
  • Assist with informed consent and ensure patients or subjects understand study requirements; follow up with participants regarding visits and compliance; monitor and report potential safety issues to the PI, Physician, and Nurse Practitioner.
  • Collect and audit patient and research data, including medical-chart data, data for publications, and data from outside physician offices; manage database data and prepare forms and reports.
  • Screen potential participants for eligibility, review screening elements with the PI, document screening events, and confirm willingness to participate.
  • Centrifuge, handle, store, and ship specimens as applicable; complete required clinical training and competency tests.
  • Maintain research expertise and complete 10 continuing education units in research education annually; serve as a resource to peers and collaborate across disciplines.
  • Oversee submissions to the NYU Institutional Review Board, Research on Decedents Oversight Committee, NYU Office of Clinical Trials, and other appropriate parties, as applicable; provide enrollment statistics and other required information.
  • Compile and analyze study data, prepare reports for sponsoring and regulatory agencies and other parties, and generate preliminary measurement reports for PI review.
  • Complete protocol-based assessments of study participants when trained and follow through on study items and participant needs.
  • Prepare and submit grant applications and related materials, organize submission paperwork, coordinate resolution of issues, and report to sponsors.
  • Assist in preparing preliminary budgets, review sponsor-proposed budgets and recommend changes, prepare funding reports, identify potential sponsors, and monitor trial budgets.
  • Evaluate information to make decisions, resolve complex situations, and refer unresolved issues to a supervisor with recommendations.
  • Communicate effectively with all levels of the Medical Center, maintain confidentiality of research information, and seek guidance or intervention when appropriate.
  • Provide students with technical guidance on sample preparation techniques, extraction lines, equipment, laboratory practices, and safety protocols, as applicable.
  • Ensure timely and accurate completion of research projects, demonstrate organizational Core Values, and participate in special projects and other duties as required.

Benefits

  • Comprehensive benefits and wellness package for employees and their loved ones.
  • Financial security benefits.
  • Generous time-off program.
  • Employee resource groups for peer support.
  • Holistic employee wellness program covering physical, mental, nutritional, sleep, social, financial, and preventive-care well-being.
  • Employee access to resources and services intended to support quality of life for employees and their families.
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