Research Coordinator

Weill Cornell Medicine - Qatar; New York (NY); On-site; USD 65,000 - 95,000; Full time

Job summary

Weill Cornell Medicine - Qatar is seeking a clinical research professional to monitor data management, regulatory and financial aspects of trial operations. The role coordinates special research projects, prepares internal board protocols, assists in evaluation-tool design and budgets.

The candidate will develop recruitment strategies, participate in protocol development, and conduct routine monitoring visits while collaborating with sponsor sites and study personnel to ensure compliance with

Qualifications

• 2 years of experience in health-related role, in clinical or research setting.
• Experience with regulatory policies and IRB interaction.
• Ability to coordinate protocols and recruitment processes.

Responsibilities

• Develops and implements practices to ensure research efficiency by routinely analyzing and evaluating workflow.
• Coordinates collection, compilation, documentation and analysis of clinical research data from various sites; assists in guidelines for data collection and study administration.
• Ensures compliance with SOPs, FDA, NIH regulations for reporting events to regulatory agencies.
• Develops regulatory reports and documentation per SOPs and study processes.
• Prepares study budgets for granting agencies; negotiates budgets with sites and sponsors.
• Researches recruitment strategies; uses modeling to understand outcomes and evaluates recruitment methods.
• Participates in protocol development related to patient recruitment and submits departmental protocols.
• Performs monitoring visits: pre-study, initiation, routine monitoring and closeout visits.
• Works with sponsor, site and study personnel on regulatory issues; leads regulatory training events.
• Maintains inventory of supplies and requisitions as needed; assists cost control.
• Performs other related duties as directed.

Skills

Data management

Regulatory compliance

Clinical research coordination

Budget coordination

Communication skills

Education

Bachelor's Degree in related field

Job description

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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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