Research Coordinator

Weill Cornell Medicine; New York (NY); On-site; USD 68,000 - 78,000; Full time

Job summary

Weill Cornell Medicine on the Upper East Side seeks a Research Coordinator to monitor data management, regulatory and financial aspects of clinical trial operations, and to coordinate special research projects. The role supports protocol development, prepares internal board protocols, assists in tool design, and coordinates budgets and recruitment strategies across multiple sites.

Bachelor's degree required; approximately 2 years in health-related clinical or research settings; familiarity with

Qualifications

• Bachelor's Degree in related field.
• Approximately 2 years of experience in health-related role, in 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 at all levels (senior investigators, nurses, research coordinators, lab technicians).

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.
• 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.
• Performs other related duties as directed.

Skills

Data management

Regulatory compliance

Clinical research coordination

IRB interaction

Budget management

Education

Bachelor's Degree in related field

Job description

Title: Research Coordinator

Location: Upper East Side

Org Unit: Cardiac Surgery

Work Days: Monday-Friday

Weekly Hours: 35.00

Exemption Status: Exempt

Salary Range: $68,200.00 - $77,500.00

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).

Working Conditions/Physical Demands

Standard office work

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