Research Coordinator - Heart Valve Team (Must have industry sponsored (IDE or IND) research exp[...]

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

Benefits offered by this job

Comprehensive benefits

Wellness program

Job summary

NYU Grossman School of Medicine, as part of NYU Langone Health, is recruiting a Research Coordinator for the Heart Valve Team. The role oversees regulatory activities, study operations, data management, and sponsor reporting for clinical research programs.

You will manage regulatory submissions, monitor protocol adherence, and analyze study metrics. A Bachelor’s degree and 2+ years of coordination experience are required, with a focus on compliance and efficient study performance.

Qualifications

• Bachelor's degree 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 (Word, Excel, Access, PowerPoint, Outlook) and internet applications.
• Effective oral, written, interpersonal communication skills.
• Ability to interface effectively with all levels of management and 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.
• Time management skills and ability to multitask.
• Ability to identify, analyze, and solve problems and work well under pressure.

Responsibilities

• 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 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.

Skills

Time management

Multitasking

Communication skills

Teamwork

Interpersonal skills

Problem solving

Education

Bachelor's degree in business administration or health care administration

Tools

Microsoft Office (Word, Excel, Access, PowerPoint, Outlook)

Job description

NYU Grossman School of Medicine is a top‑ranked medical school that trains physicians and scientists. It is part of NYU Langone Health and focuses on improving human health through education, research, and patient care.

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, including regulatory compliance, grant administration, budget oversight, study operations, data analysis, and sponsor reporting.

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

• 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 (Word, Excel, Access, PowerPoint, Outlook) and internet applications.
• Effective oral, written, interpersonal communication skills.
• Ability to interface effectively with all levels of management and 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.
• Time management skills and ability to multitask.
• Ability to identify, analyze, and solve problems and 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

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

Benefits

Comprehensive benefits and wellness program, including financial security benefits, generous time‑off, employee resource groups, and a holistic wellness program focusing on physical, mental, nutritional, sleep, social, financial, and preventive care.

Salary

Salary range: $66,299.99 – $66,300.00 annually. Actual salaries depend on experience, education, and other factors. The range does not include bonuses, differential pay, or other compensation.

Equal Opportunity Employer

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