Clinical Research Coordinator I - PACC

Columbia University Irving Medical Center is hiring a Clinical Research Coordinator I to support research studies and clinical trials in its Division of Pulmonary, Allergy and Critical Care Medicine. The role coordinates participant activities, study data and documentation, protocol compliance, and collaboration across research teams and stakeholders.

Responsibilities

Assist with the day-to-day execution of study protocols, including participant recruitment, screening, enrollment, follow-up activities, specimen processing, and other protocol-related tasks under direct supervision

Establish and maintain effective working relationships with study participants, clinicians, healthcare providers, sponsors, and research office staff to facilitate successful study operations

Support the coordination of research team meetings, investigator meetings, sponsor visits, external audits, and other stakeholder engagement activities

Assist research team members with various clinical trial and study-related responsibilities

Ensure timely communication among Principal Investigators, compliance offices, and study sponsors

Perform data entry and data management activities under supervision. Data may include protected health information (PHI), clinical data, billing information, and other administrative records

Maintain complete and accurate research files, including administering questionnaires, preparing and completing case report forms (CRFs), compiling regulatory documentation, supporting study start-up and close-out activities, and assisting with adverse event (AE) reporting

Demonstrate an understanding of Corrective and Preventive Action (CAPA) processes and related compliance requirements. Coordinate study-related financial transactions, including participant compensation, and assist participants in resolving payment issues

Adhere to workplace and patient safety standards, monitor study environments for compliance with ethical and safety requirements, and maintain research supply inventories, requesting additional materials as needed

Serve as a frontline representative of Columbia University Irving Medical Center research programs and utilize culturally responsive communication practices when interacting with study participants

Perform additional duties and responsibilities as assigned

Preferred

Bilingual in English and Spanish

At least two years of experience in a clinical research setting or related field

Familiarity with Columbia University health and research systems

Educational background in a scientific, healthcare-related, or business administration discipline, or experience with observational research and/or laboratory environments

Experience using electronic medical records and research databases, including Epic, REDCap, Qualtrics, iLab, and OpenSpecimen

Knowledge of clinical research operations, Good Clinical Practice (GCP) guidelines, HIPAA regulations, Columbia Institutional Review Board (IRB) requirements, and other applicable institutional and federal regulatory standards

At least two years of experience in a clinical research setting or related field.

English-Spanish Bilingual

Clinical Research Experience

Columbia Health Systems Familiarity

Columbia Research Systems Familiarity

Scientific Education

Healthcare Education

Business Administration Education

Observational Research Experience

Laboratory Experience

Electronic Medical Records

Research Databases

Epic

REDCap

Qualtrics

iLab

OpenSpecimen

Clinical Research Operations

Clinical Practice (GCP)

HIPAA Regulations

Columbia IRB Requirements

Institutional Regulatory Standards

Federal Regulatory Standards

Company

Academic medical center providing patient care, research, and education.

New York, New York, USA

https://www.cuimc.columbia.edu/

Founded in 1767

10001+ employees

Qualifications

Bachelor's degree or an equivalent combination of education, training, and experience

Strong customer service orientation with the ability to collaborate effectively with diverse stakeholders

Ability to work independently and as part of a team in a fast-paced, deadline-driven environment while managing multiple priorities

Demonstrated commitment to fostering diversity, equity, inclusion, and belonging

Proficiency with Microsoft Office applications, including strong Excel skills

Ability and willingness to learn new systems, technologies, and research-related applications

Bilingual in English and Spanish

At least two years of experience in a clinical research setting or related field

Familiarity with Columbia University health and research systems

Educational background in a scientific, healthcare-related, or business administration discipline, or experience with observational research and/or laboratory environments

Experience using electronic medical records and research databases, including Epic, REDCap, Qualtrics, iLab, and OpenSpecimen

Knowledge of clinical research operations, Good Clinical Practice (GCP) guidelines, HIPAA regulations, Columbia Institutional Review Board (IRB) requirements, and other applicable institutional and federal regulatory standards

Required skills

Microsoft Excel, Microsoft Office, Clinical Research, Epic, REDCap, Qualtrics, iLab, OpenSpecimen, Clinical Practice (GCP), HIPAA, Institutional Review Board (IRB) Requirements, Observational Research

Preferred skills

Bilingual in English and Spanish, Glassdoor, 3.5, New York, New York, USA, https://www.cuimc.columbia.edu, Late Stage, Leadership Team, Donna Lynne, Senior Vice President and COO, Recent News, Genetic Engineering News, 2026-05-30, News-Medical.Net, 2026-05-29, PR Newswire, 2026-04-23, Company data provided by, AI Tools, Customize Your Resume, Maximize your interview chances, Build Cover Letter, Make your application stand out, Analyze How Well You Fit, Understand your strength & weakness

Experience

2+ years