Research Coordinator - Heart Valve Team (Must have industry sponsored (IDE or IND) research experience)

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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Position Summary

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

Responsible for the administration, coordination, and operational management of clinical research studies and sponsored research programs for the Heart Valve Team. Independently manages research activities across multiple studies, including regulatory compliance, grant administration, budget oversight, study operations, data analysis, and sponsor reporting. Serves as a key resource to Principal Investigators and research leadership by interpreting research requirements, evaluating study performance, identifying operational risks, and recommending solutions to support successful study execution and compliance with institutional, sponsor, and regulatory requirements.

Job Responsibilities

Human Subjects Research Administration

• 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.

Study Operations and Regulatory 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.

Data Management, Reporting, and Analysis

• 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.

Budget and Financial Management

• 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.

Decision-Making and Problem Solving

• 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.

Participant Recruitment and Study Management

• 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.

Clinical Research Activities

• May perform study-specific clinical procedures, including specimen collection, electrocardiograms, specimen processing, storage, and shipment, as required by protocol and training.
• Evaluates participant safety concerns and ensures appropriate escalation to investigators and clinical leadership.
• Maintains required clinical competencies and certifications necessary to support study operations.

Continuous Learning and Professional Development

• Maintains expertise in clinical research regulations, study management practices, and sponsor requirements through ongoing professional development.
• Participates in continuing education and maintains required research certifications and training.
• Serves as a resource to investigators, study teams, and colleagues regarding research operations, regulatory compliance, and study management best practices.

Reporting and Scientific Support

• Develops study reports and research summaries for investigators, sponsors, regulatory agencies, and institutional leadership.
• Assists in the preparation of abstracts, presentations, publications, and other scholarly dissemination activities.
• Evaluates study outcomes and prepares analyses and recommendations to support future research initiatives.
• Provides regular updates regarding study progress, enrollment performance, regulatory status, and operational metrics to investigators and leadership.

Additional Position Specific Responsibilities:

Participates in departmental initiatives, strategic projects, and process improvement efforts.

Performs other related duties as assigned.

Minimum Qualifications

To qualify you must have a Bachelor degree or equivalent in business administration, health care administration or related field.

Minimum of two years of progressively responsible project coordination experience, preferably in a research setting.

Proficiency in using various Microsoft Office applications such as Word, Excel, Access, Power Point and Outlook. Familiar with Internet applications.

Effective oral, written, communication, interpersonal skills.

Ability to interface effectively with all levels of management and must work and communicate effectively with both internal and external customers.

Ability to work within a team environment as well as independently.

Commitment to continuous learning as required by department administration.

Ability to operate research related equipment

Ability to work and make decisions independently.

Time management skills and ability to multitask.

Ability to identify, analyze and solve problems: Ability to work well under pressure.

Preferred Qualifications

Clinical Research Coordinator (CRC) Certification is preferred (required in some disciplines).

Knowledge of basic medical terminology is preferred.

Experience working in an Academic Medical Center preferred

Qualified candidates must be able to effectively communicate with all levels of the organization.

NYU Grossman 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. At NYU Langone Health, we are committed to supporting our workforce and their loved ones with a comprehensive benefits and wellness package. Our offerings provide a robust support system for any stage of life, whether it's developing your career, starting a family, or saving for retirement. The support employees receive goes beyond a standard benefit offering, where employees have access to financial security benefits, a generous time-off program and employee resources groups for peer support. Additionally, all employees have access to our holistic employee wellness program, which focuses on seven key areas of well-being: physical, mental, nutritional, sleep, social, financial, and preventive care. The benefits and wellness package is designed to allow you to focus on what truly matters. Join us and experience the extensive resources and services designed to enhance your overall quality of life for you and your family.

NYU Grossman School of Medicine is an equal opportunity employer and committed to inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration. We require applications to be completed online.

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NYU Langone Health provides a salary range to comply with the New York state Law on Salary Transparency in Job Advertisements. The salary range for the role is $66,299.99 - $66,300.00 Annually. Actual salaries depend on a variety of factors, including experience, specialty, education, and hospital need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.

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