Research Coordinator

Weill Cornell Medical College•New York, NY

3d•$68,200 - $77,500•Onsite

About The Position

Under direction, the Research Coordinator monitors data management, regulatory, and financial aspects of clinical trial operations. The role also coordinates special research projects, prepares internal board protocols for clinical research, assists in designing evaluation tools and instruments, and coordinates budgets. The position develops and evaluates research workflows, coordinates clinical research data across sites, and supports the collection and administration of clinical studies. It ensures compliance with applicable regulatory requirements and study processes, prepares regulatory documentation, and works with sponsors, sites, and study personnel on regulatory matters. The coordinator also develops recruitment strategies, participates in protocol development related to recruitment and retention, and conducts study monitoring visits. The role prepares and negotiates study budgets, develops policies and procedures, provides regulatory training, and maintains inventories of supplies, equipment, and reagents. Other related duties may be assigned.

Requirements

Bachelor's degree in a related field.
Approximately 2 years of experience in a health-related role in a clinical or research setting.
Experience 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 involving senior investigators, nurses, research coordinators, and lab technicians.

Responsibilities

Develop and implement practices to improve research efficiency by analyzing and evaluating workflow.
Coordinate the collection, compilation, documentation, and analysis of clinical research data from clinical sites.
Assist in establishing guidelines for clinical data collection and administration of clinical studies.
Ensure general and study-specific regulatory processes comply with SOPs, FDA and NIH requirements, and applicable regulations for reporting events to regulatory agencies.
Develop regulatory reports and related documentation in accordance with SOPs and study-specific processes.
Prepare study budgets for granting agencies and negotiate budgets with sites, departments, and sponsors.
Research and develop recruitment strategies; use modeling and simulation tools to assess current and projected outcomes of recruitment techniques; and monitor and evaluate recruitment methods.
Participate in protocol development related to patient recruitment, and prepare and submit departmental protocols related to subject recruitment and retention.
Perform pre-study, initiation, routine monitoring, and closeout visits.
Work with sponsors, sites, and study personnel on regulatory issues.
Develop policies and procedures for regulatory and monitoring processes, and lead regulatory training events for personnel at various sites.
Maintain inventories of supplies, equipment, and reagents; order items when authorized or escalate needs, receive orders, confirm delivery accuracy, and assist with cost control.
Perform other related duties as directed.