Research Coordinator, Regulatory & Business Engagement, Crohn's and Colitis Foundation

The Organization

The Crohn’s & Colitis Foundation, Inc is a private, non-profit national organization dedicated to finding the cure for Crohn’s disease and ulcerative colitis and improving the quality of life of children and adults affected by these diseases. We fund cutting-edge studies at major medical institutions, nurture investigators at the early stages of their careers, and finance underdeveloped areas of research. In addition, our educational workshops and programs, along with our scientific journal, Inflammatory Bowel Diseases, enable medical professionals to keep pace with this rapidly growing field. Crohn’s & Colitis Foundation’s core values of compassion, integrity, leadership, collaboration, and inclusion inspire and drive every member of our highly performing team.

Position Overview

The Research Coordinator, Regulatory and Business Engagement is a new role at the Crohn’s & Colitis Foundation (Foundation). The Research Coordinator will be responsible for providing research coordination and regulatory management for active studies within the research department of the Foundation. As well, this role will work to build positive client relationships and provide efficient and effective delivery of research support to participating sites. This includes coordinating new site onboarding and training, regulatory management, liaising with database managers, development of study-related materials, site troubleshooting and communication with participating clinical centers and team members.
This position is critical and serves as a linchpin for research cohort team. The ideal candidate must be a highly motivated and self-directed team player that can learn quickly, excel, and work independently in a fast-paced and complex environment. The individual must be organized, reliable, detail-oriented, and be able to work collaboratively with team members.

REPORTS TO: Manager, IBD Qorus Clinical Operations

LOCATION: The Foundation is a national organization with headquarters in New York and 39 chapters across the country. Candidates that are within commuting distance of the Foundation’s headquarters in New York City are preferred. Remote candidates will also be considered.


Research Coordination / Regulatory Management
• Coordinate and facilitate regulatory and contracting activities across active studies
• Plan study start-up activities to ensure successful recruitment and delivery to milestones
• Track and monitor progress towards milestones across the various cohorts and programs
• Run routine site progress reports including patient enrollment, missing data queries, etc. and proactively follow-up with sites to resolve or improve
• Partner with IBD Plexus team to engage sites in EMR extraction efforts; coordinate initiative kick-off meetings, facilitate team engagement and understanding of the process, and monitor sites progress towards EMR extraction execution
• Track program’s financial activities including revenue from supporting partners, invoices for meeting expenses or program activities, and generation of detailed expense reports
• Assist in program related projects with multi-disciplinary team members (program chairs, site providers and care teams, patients)

Client Engagement
• Build and maintain positive client relationships (client = clinical care site teams) throughout the program or research study
• Interface with participating clinical sites for onboarding, training, and troubleshooting
• Develop and maintain site training and recruitment materials
• Facilitate timely, succinct, and straightforward communication with clients and with internal team members
• Identify and organize client needs; Assist in addressing and resolving those needs

Administrative support
• Assist with logistics organization and planning during program meetings and webinars
• Prepare and process study invoices, honorariums, reimbursements, and travel expenses
• Organize and maintain program filing / storage drives
• Set-up and manage webinars / teleconferences; Transcribe meeting minutes and distribute accordingly
• Interface with the grants management team to comply with internal policies (i.e., posting
award announcements, uploading financial and progress reports, etc.)


Education and Work Experience:
• Bachelor’s Degree in a health care related field
• 3+ years of health-related project coordination experience
• Experience working within an academic institution and experience working on or within a
consortium based multi-center initiative is preferred
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory
• Certificate of training for Human Subjects Research; Clinical Research certification(s)
• Working knowledge of patient recruitment, retention, and compliance strategies
• Experience with data extraction for research purposes
• Basic understanding of electronic medical record systems (EPIC, Cerner) and electronic
data capture systems (REDCap, Medidata)
• Experience working with central IRBs and Contract Research Organizations a plus

Professional Competencies and Skills:
• Exceptional organizational skills
• Proactive trouble shooter and open minded; sound judgement and understanding when
escalation is needed
• Careful attention to detail and meticulous
• Excellent verbal and written communication skills
• Analytical ability to sufficiently enter and organize data or results (feedback, updates, etc.)
• Personable; collaborative attitude; strong ability to work well with others
• Capacity to handle multiple activities simultaneously and effectively prioritize tasks
• Ability to work and adapt under tight deadlines, and to identify and troubleshoot issues
• Able to work normal business hours
• Ability to travel occasionally (post COVID)

How To Apply

*Please follow the link below to submit an online application via the Crohn’s & Colitis Career page.

Job link:

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