Research Coordinator

Weill Cornell Medicine; New York (NY); On-site; USD 70,000 - 90,000; Full time

Job summary

Weill Cornell Medicine in New York City seeks a data management and regulatory coordinator to oversee the clinical trial operations, data handling, and regulatory compliance across multiple sites. The role supports protocol design, budgeting, and recruitment efforts within an academic health center environment.

You will collaborate with investigators, study staff, and sponsors to ensure adherence to SOPs, FDA/NIH regulations, and study timelines while contributing to the efficiency and integrity

Qualifications

• Experience coordinating clinical research and data management.
• Familiarity with IRB interaction and regulatory policies.
• Experience in academic health centers with cross-team collaboration.

Responsibilities

• Monitors data management, regulatory and financial aspects of clinical trial operations.
• Coordinates collection and analysis of clinical research data from multiple sites.
• Ensures compliance with SOPs, FDA, NIH regulations and reporting requirements.
• Develops regulatory reports and documentation per SOPs.
• Prepares study budgets and negotiates with sites and sponsors.
• Develops recruitment strategies and analyzes recruitment effectiveness.
• Participates in protocol development related to subject recruitment and retention.
• Performs monitoring visits (pre-study to closeout).
• Collaborates with sponsor, site, and study personnel on regulatory issues and training.
• Maintains inventory of supplies and assists cost control.
• Performs other related duties as directed.

Education

Bachelor's Degree in related field

Job description

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*As required under NYC Human Rights Law Int 1208-2018 - Salary range for this role when Hired for NYC Offices

Position Summary

Under direction, monitors all data management, regulatory and financial aspects of clinical trial operations. This role also coordinates special research projects, prepares internal board protocols for clinical research, assists in the design of evaluation tools/instruments and coordinates budgets.

Job Responsibilities

• Develops and implements practices to ensure research efficiency by routinely analyzing and evaluating workflow.
• Coordinates the collection, compilation, documentation and analysis of clinical research data from various clinical sites. Assists in the determination of guidelines for the collection of clinical data and or administration of clinical studies.
• Ensures compliance of general and study specific regulatory related processes with SOPs, FDA, NIH, and applicable regulations for the reporting of events to regulatory agencies.
• Develops regulatory reports and associated documentation in accordance with SOPs and study specific processes.
• Prepares study related budgets for granting agencies. Negotiates study related budgets with various sites, departments and sponsors.
• Researches and develops the recruitment strategies. Employs modeling and simulation tools to understand the current and projected outcome of recruitment techniques. Monitors and evaluates the success of varying subject recruitment techniques.
• Participates in protocol development as it relates to patient recruitment. Assesses, analyzes, prepares and submits departmental protocols to various places as it relates to subject recruitment and retention.
• Performs monitoring visits: pre-study, initiation, routine monitoring and closeout visits.
• Works closely with sponsor, site and study personnel on relevant regulatory issues. Develops policies and procedures pertaining to regulatory and monitoring processes. Leads regulatory educational training events for personnel at various sites.
• Maintains inventory of supplies, equipment and/or reagents. May order supplies/equipment/reagents as authorized or ensure that needs are escalated appropriately. Receives supply orders and confirms accuracy of delivery. May assist with cost control.
• Performs other related duties as directed.

Education

• Bachelor's Degree in related field

Experience

Approximately 2 years of experience in health-related role, in clinical or research setting

Knowledge, Skills and Abilities

• Experience with conducting and carrying out protocols and research coordination.
• Familiarity with IRB interaction, regulatory policies, database input and report generation.
• Research experience in an academic health center with exposure to a team research environment at all levels (senior investigators, nurses, research coordinators, lab technicians).

Licenses and Certifications

Working Conditions/Physical Demands

Standard office work

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