Research Coordinator

Location: Upper East Side, NYC • Monday–Friday • 35 hours/week • Exempt

About the role

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

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 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 budgets with sites, departments, and sponsors.
• Researches and develops recruitment strategies; employs modeling and simulation tools to project recruitment outcomes.
• 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 relevant bodies for subject recruitment and retention.
• Performs monitoring visits: pre-study, initiation, routine monitoring, and close-out visits.
• Works closely with sponsor, site, and study personnel on 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 or escalate needs.
• Receives supply orders and confirms accuracy of delivery; may assist with cost control.
• Performs other related duties as directed.

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 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.

Pay

$68,200 – $77,500 per year.