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

NYU Langone Health; New York (NY); On-site; USD 66,299 - 66,300; Full time

Job summary

NYU Langone Health is seeking a Research Coordinator for the Heart Valve Team to manage regulatory and operational aspects of clinical research. You will coordinate IRB submissions, monitor study progress, and ensure compliance across multiple studies, supporting investigators and leadership.

Responsibilities include data management, budget oversight, and preparing reports for sponsors and regulatory agencies. Strong communication and organizational skills are essential for success.

Qualifications

• Bachelor's degree or equivalent required.
• Minimum of two years of progressively responsible project coordination experience.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Excellent communication and interpersonal skills.
• Ability to interface with management and external partners.

Responsibilities

• Coordinate regulatory activities to obtain and maintain human subjects approvals.
• Interpret applicable institutional, sponsor, and regulatory requirements.
• Prepare submissions to IRB and clinical trials offices.
• Monitor regulatory documentation for lifecycle compliance.
• Provide guidance on protocol requirements and study procedures.
• Oversee study operations, enrollment, and milestones.
• Analyze data trends and generate study metrics for reports.
• Assist with budget oversight and sponsor reporting.
• Support investigators and leadership with operational improvements.

Skills

Regulatory coordination

Communication

Data management

Project coordination

Education

Bachelor's degree or equivalent in health care administration, business or related field

Tools

Microsoft Office

Job description

Position Summary

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

• Performs 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

• Bachelor's 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 Microsoft Office applications (Word, Excel, Access, PowerPoint, Outlook) and internet applications.
• Effective oral, written, and interpersonal communication skills.
• Ability to interface effectively with all levels of management and to work with both internal and external customers.
• Team player who can also work independently.
• Commitment to continuous learning as required by department administration.
• Ability to operate research‑related equipment.
• Strong time‑management and multitasking skills.
• Analytical and problem‑solving skills, with the ability to work well under pressure.

Preferred Qualifications

• Clinical Research Coordinator (CRC) certification preferred (required in some disciplines).
• Basic medical terminology knowledge preferred.
• Experience working in an academic medical center preferred.

Equity, Diversity, and Inclusion

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.

Salary Transparency

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.

Application Instructions

Applications must be completed online.