Clinical Research Coordinator I - PACC

• Job Type: Officer of Administration
• Regular/Temporary: Regular
• Hours Per Week: 35
• Salary Range: $66,300.00 - $68,290.00

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

Columbia University Irving Medical Center (CUIMC) provides global leadership in scientific research, health and medical education, and patient care. Working in the Division of Pulmonary, Allergy and Critical Care Medicine under the direction of the Principal Investigators, the Clinical Research Coordinator I (CRC I) supports research studies and clinical trials managed by the Division.

The CRC I is responsible for coordinating participant involvement, including screening, recruitment, assessments, and follow-up activities; collecting and maintaining study data; ensuring adherence to protocol requirements; and collaborating with members of the research team to support all aspects of clinical trial and research study operations.

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.

Minimum 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.

Preferred Qualifications

• 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.

Other Requirements

• Medical clearance and participation in medical surveillance program.
  • Contact with patient and/or human research subjects.
• 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.