Senior Coordinator, Clinical Research

Crohn's & Colitis Foundation; New York (NY); Remote; USD 66,000 - 72,000; Full time

Job summary

The Crohn's & Colitis Foundation is seeking a Senior Coordinator for their Clinical Research team. This role focuses on enhancing clinical trial participation and managing operational support for research initiatives. Ideal candidates will possess a related Bachelor's degree and experience in research coordination, demonstrating excellent organizational and communication skills.

Qualifications

• 3+ years of relevant experience as a research coordinator.
• Knowledge of Good Clinical Practice/ICH Guidelines.
• Experience in a medical institution or consortium-based research preferred.

Responsibilities

• Lead the Clinical Trials Accelerator program.
• Conduct monitoring and auditing visits for enrolled sites.
• Assist in developing educational materials for study coordinators.

Skills

Organizational skills

Attention to detail

Excellent communication

Ability to prioritize

Education

Bachelor's degree in related field

Tools

Microsoft Office

Job description

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Crohn's & Colitis Foundation provided pay range

This range is provided by Crohn's & Colitis Foundation. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$66,000.00/yr - $72,000.00/yr

The Crohn’s & Colitis Foundation is a non-profit, volunteer-fueled organization whose mission is to cure Crohn’s disease and ulcerative colitis and improve the quality of life for the children and adults affected by these diseases. Our work is dramatically accelerating the research process through our varied research initiatives; we also provide extensive educational and support resources for patients and their families, medical professionals, and the public. In addition, we lead federal and state-based advocacy campaigns to support medical research funding and improve patient access to care. The Foundation’s core values of compassion, integrity, leadership, collaboration, and inclusion inspire and drive every member of our highly performing team.

Position Summary

Accelerating access to improved therapies through clinical trials is central to the Foundation’s mission. The Foundation educates and supports patients interested in clinical trials and collaborates with gastroenterology professionals and researchers to enhance trial awareness and efficiencies. Despite over 70 active clinical trials available for patients with IBD in the United States, enrollment remains limited. To address this, the Foundation has launched a Clinical Trial Accelerator (CTA) program, aiming to expand the number and diversity of sites participating in clinical trials.

The Senior Coordinator, Clinical Research will play a pivotal role in the Clinical Trials Accelerator (CTA) program, providing remote operational support to participating trial sites. This role involves close collaboration with principal investigators, research staff, and external partners, and focuses on identifying and addressing common challenges to expedite trial activation and patient enrollment. Support spans the entire clinical trial lifecycle – including start-up, regulatory compliance, patient recruitment and retention, data management, study communication, monitoring and quality assurance, and documentation and progress reporting.

Reporting to the Associate Director of Clinical Research, the Senior Coordinator will also assist in the day to-day management of two of the Foundation’s prospective, longitudinal research cohorts: IBD SIRQC (Surgical Innovation, Research and Quality Collaborative) and CAPTURE IBD (Cohort for Pediatric Translational and Clinical Research in IBD). Responsibilities include ensuring adherence to best practices across participating sites, adjudicating payments for research activities, and implementing data and biosample quality management plans.

This is a remote position.

Essential Functions & Responsibilities

Study Conduct

• Serve as the Foundation lead for the CTA program, and main point of contact for CTA participating sites. Interface regularly with site principal investigators, study coordinators, and external vendor teams.
• Familiarize and learn all aspects of each CTA study including training, data and biosamples collection to be a resource for sites
• Demonstrate expertise, knowledge & experience in coordination of prospective clinical research studies and clinical trials
• Engage with study site coordinators in identifying strategies to improve screening, recruitment, data/samples standardization and quality. Proactively identify and monitor barriers to achieve these goals and problem solve or innovate to overcome them
• Conduct on-site and remote monitoring and/or auditing visits for enrolled sites, site initiation and generate monitoring report(s) as appropriate
• Review data entry and undertake a validation process to ensure accuracy, quality, completeness, and compliance with data and biosample collection processes
• Prepare reports on study activities: enrollment, data/biosamples quality checks and completeness reports. Communicate findings to cohort team leadership and the Associate Director, Clinical Research
  
  

Training

• Assist in developing and delivering guidelines and educational materials for study coordinators
• Train new coordinators; maintain training and onboarding for sites
• Create training materials for sites and engagement materials for patients and study staff
• Work with site coordinators on data/biosamples query resolution and data revisions, as needed
• Collaborate with IRB of record to facilitate compliance, training and regulatory documentation needed for each site, and ensure the virtual regulatory binder is up to date and accurate
  
  

Administrative

• Manage and process site invoices and study participants’ incentive payments
• Assist with scheduling, writing and distributing meeting minutes
• Provide support on maintaining study timelines and sponsor commitments
• Identify and escalate issues appropriately to the Associate Director, Clinical Research
  
  

Qualifications

Training & experience

• A bachelor’s degree in related field preferred
• 3+ years of relevant experience as a research coordinator with involvement in recruitment, eCRFs & biosamples collection, processing, and shipping
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Experience in a medical institution; especially working on or within consortium based multicenter research initiatives, preferred
• Certified Clinical Research Coordinator, preferred (ACRP or SOCRA)
  
  

Competency And Skills

• Ability to build excellent working relationships both internal and external to the organization
• Capacity to handle multiple activities simultaneously and effectively prioritize tasks
• Extremely detail oriented
• Excellent organizational skills
• Excellent oral and written English communication skills
• Proficiency in Microsoft Office
• Self-starter, willingness to learn various business/technical skills and systems
• Resourceful and proactive
• Ability to travel (approximately 10%)

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Non-profit Organizations

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