Research Coordinator - Heart Valve Team; industry ; IDE or IND) research exp

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 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 inclusion and individual skills, ideas, and knowledge.

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We have an exciting opportunity to join our team as a Research Coordinator - Heart Valve Team.

• Independently coordinates regulatory activities required to obtain and maintain approval for human subjects research.
• Interprets and applies institutional, federal, sponsor, and regulatory requirements governing research studies.
• Oversees preparation and submission of materials to the Institutional Review Board (IRB), Office of Clinical Trials, and other regulatory entities.
• Ensures regulatory documentation remains current, complete, and compliant throughout the lifecycle of each study.
• Evaluates regulatory requirements and recommends actions to investigators and study teams to ensure ongoing compliance.

• Oversees study implementation and operational management for assigned research protocols.
• Monitors protocol adherence, enrollment activity, regulatory requirements, and study milestones.
• Identifies operational, compliance, and participant-related issues and develops recommendations to address concerns.
• Provides guidance to study personnel regarding protocol requirements, regulatory expectations, and study procedures.
• Evaluates study performance metrics and recommends process improvements to enhance operational effectiveness and participant retention.

• Oversees the collection, validation, management, and integrity of research data.
• Reviews and analyzes study data, enrollment trends, protocol compliance metrics, and operational performance indicators.
• Develops reports, summaries, statistical analyses, and study metrics for investigators, sponsors, regulatory agencies, and institutional leadership.
• Interprets research data and prepares findings and recommendations to support study management and decision-making.
• Ensures accuracy and completeness of research databases and reporting systems.

• Develops preliminary study budgets and funding projections for investigator review.
• Reviews sponsor-proposed budgets, evaluates financial feasibility, and recommends modifications to ensure appropriate study funding.
• Monitors study expenditures and resource utilization throughout the life of the project.
• Analyzes budget performance and identifies financial risks, funding gaps, or operational concerns requiring intervention.
• Assists with preparation of financial reports and funding documentation for sponsors and regulatory agencies.

• Exercises independent judgment in evaluating study operations, regulatory requirements, participant issues, and research-related challenges.
• Analyzes complex information from multiple sources and determines appropriate courses of action to support study objectives.
• Resolves operational and regulatory issues within established authority and escalates significant concerns with recommendations for resolution.
• Develops and implements process improvements to enhance research operations, compliance, efficiency, and study performance.

• Oversees participant recruitment strategies and evaluates eligibility determinations in accordance with protocol requirements.
• Reviews participant screening outcomes and enrollment activities to ensure compliance with inclusion and exclusion criteria.
• Provides guidance regarding informed consent requirements and participant engagement strategies.
• Monitors participant retention and protocol adherence and recommends corrective actions when necessary.

• May perform study-specific clinical…