Clinical Research Coordinator I - CCTI

Columbia University in the City of New York; New York (NY); On-site; USD 66,000 - 68,000; Full time

Job summary

The Columbia Center for Translational Immunology (CCTI) at Columbia University Irving Medical Center seeks a Clinical Research Coordinator to support transplant research using patient-derived samples and humanized mouse models. Responsibilities include data collection, IRB protocol maintenance, specimen coordination, and HLA typing data assembly.

Reporting to the Laboratory Director, the role requires strong organization, attention to detail, and collaboration with a multidisciplinary team.

Qualifications

• Bachelor's degree in Immunology, Biology, Life Sciences, Public Health or related field.
• Excellent interpersonal, written and verbal communication with multidisciplinary teams.
• Ability to independently manage complex tasks while following regulations.

Responsibilities

• Process and manage clinical specimens and data.
• Maintain accurate study records and databases.
• Coordinate IRB protocols and regulatory documentation.
• Recruit, enroll, and follow study participants; manage sample processing.
• Collaborate with investigators and IRBs to ensure compliance with protocols.
• Prepare and submit regulatory amendments and continuing reviews.

Skills

Interpersonal skills

Organizational skills

Communication skills

Attention to detail

multitasking

Education

Bachelor's degree in Immunology, Biology, Life Sciences, Public Health

Tools

EPIC EMR

UNOS database

Microsoft Word/Excel/PowerPoint

Job description

• Job Type: Officer of Administration
• Regular/Temporary: Regular
• Hours Per Week: 35
• Salary Range: $66,300.00 - $68,000.00

The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.

Position Summary

The Columbia Center for Translational Immunology (CCTI) at Columbia University Irving Medical Center (CUIMC) seeks a highly motivated and talented Clinical Research Coordinator to join its research team. The Coordinator will support laboratory and clinical research studies involving transplant recipients and humanized mouse models generated using patient-derived bone marrow stem cells.

Primary responsibilities include data collection and analysis before and after organ transplantation, maintenance of Institutional Review Board (IRB) protocols, coordination of specimen collection and processing, database management, and support of translational immunology research initiatives. Working within CCTI, the Coordinator will recruit and enroll study participants, coordinate specimen collection and processing, obtain and compile HLA typing data, and assist with the development and analysis of human immune system mouse models.

The Coordinator will report to the Laboratory Director and will maintain specimen inventories, manage sample distribution to laboratory personnel, and support biobanking operations. The successful candidate must possess strong organizational and interpersonal skills, a solid understanding of basic laboratory techniques, exceptional attention to detail, and a demonstrated commitment to scientific integrity and professional excellence.

Responsibilities

• Process and manage human biological specimens.
• Maintain accurate specimen records and databases.
• Order laboratory supplies and manage inventory levels.
• Monitor, maintain, and coordinate servicing of laboratory equipment.
• Assist with billing and invoicing for Biobank services.
• Collaborate with investigators, the Scientific Review Committee (SRC), and Institutional Review Boards (IRBs) to ensure compliance with study protocols and regulatory requirements.
• Obtain, process, and store fetal tissue in accordance with study protocols and applicable federal, state, institutional, and laboratory policies.
• Participate in clinical research studies involving transplantation.
• Recruit, enroll, and follow study participants; assist with human sample processing and data analysis.
• Process and ship blood, lymphoid tissue, intestinal tissue, bone marrow, and stool specimens in accordance with sponsor protocols and applicable federal, state, and institutional regulations.
• Isolate genomic DNA (gDNA) from collected specimens and coordinate HLA typing and single nucleotide polymorphism (SNP) analyses.
• Compile, analyze, and disseminate HLA typing results for donors and transplant recipients.
• Collect, manage, and analyze clinical data from EPIC electronic medical records and the UNOS donor database, including demographic information, HLA typing, immunosuppression regimens, episodes of rejection and infection, donor-specific antibody (DSA) development, and other clinical outcomes.
• Participate in Human Studies Core projects and interlaboratory collaborative studies.
• Maintain protocol-specific regulatory documents, study files, and research records; enter and manage study data within centralized and study-specific databases.
• Attend and actively participate in laboratory meetings, data monitoring meetings, and scientific seminars; provide updates on recruitment, study progress, and research activities.
• Report to the Principal Investigator and Laboratory Director within CCTI and the Department of Medicine.
• Prepare, submit, and maintain IRB protocols, amendments, continuing reviews, and related regulatory documentation.
• Process invoices and assist with financial reconciliation activities for the Human Studies Core.
• Perform additional duties as assigned.

Minimum Qualifications

• Bachelor's degree in Immunology, Biology, Life Sciences, Public Health, or a related field, or an equivalent combination of education and experience.
• Excellent interpersonal, written, verbal, organizational, and communication skills, with the ability to work effectively with clinical populations and multidisciplinary teams.
• Demonstrated ability to independently manage complex tasks while exercising sound judgment and adhering to all federal, state, institutional, and departmental regulations and guidelines.
• Strong attention to detail and ability to manage multiple priorities simultaneously.
• Ability to work both independently and collaboratively within research and clinical environments.
• Commitment to a minimum two-year term in the position.

Preferred Qualifications

• Minimum of two (2) years of related experience in clinical research and/or a patient care setting.
• Eligibility to sit for ACRP or SOCRA certification examinations.
• Experience in clinical research coordination, specimen processing, transplant research, or immunology research.
• Self-motivated and highly organized, with the ability to work in a fast-paced research environment.
• Proficiency with Microsoft Word, Excel, PowerPoint, and electronic data management systems.
• Phlebotomy experience and certification preferred.

Other Requirements

• Medical clearance and participation in the medical surveillance program.
  • Laboratory animals
  • Contact with patients and/or human research subjects
  • Potential bloodborne pathogen exposure
• Successful completion of applicable compliance and systems training requirements.

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.