Clinical Research Coordinator III - PACC

• Job Type: Officer of Administration
• Regular/Temporary: Regular
• Hours Per Week: 35
• Salary Range: $84,872 - $84,872

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) is a leader in scientific research, medical education, and patient care. Reporting to the Principal Investigator, Dr. Matthew Baldwin, within the Division of Pulmonary, Allergy & Critical Care, the Clinical Research Coordinator III (CRC III) is responsible for the coordination and administration of complex clinical research studies and trials.

The CRC III independently manages day-to-day research operations, including participant recruitment, screening, enrollment, study visits, data collection, regulatory documentation, specimen processing, and study closeout activities. The incumbent ensures compliance with study protocols, sponsor requirements, institutional policies, and applicable regulatory guidelines. The CRC III also serves as a resource to junior research staff, contributes to process improvement initiatives, and supports study monitoring and audit activities.

This position requires strong project management, analytical, and communication skills, as well as the ability to effectively collaborate with investigators, sponsors, participants, and regulatory stakeholders. Prior clinical research experience in an academic medical center environment is strongly preferred.

Responsibilities

• Coordinate all aspects of assigned clinical research studies, including participant recruitment, screening, enrollment, scheduling, retention, follow-up, and study closeout activities.
• Maintain study compliance with protocol requirements, sponsor expectations, institutional policies, Good Clinical Practice (GCP), HIPAA, and applicable federal regulations.
• Develop and implement participant recruitment and retention strategies tailored to target study populations.
• Serve as a primary liaison among investigators, study participants, sponsors, regulatory offices, and clinical staff.
• Coordinate investigator meetings, sponsor visits, monitoring visits, audits, and other study-related activities.
• Ensure timely communication of study updates, protocol deviations, adverse events, and regulatory matters to the Principal Investigator and appropriate oversight offices.
• Enter, validate, and maintain research data in electronic systems while ensuring data integrity, accuracy, completeness, and confidentiality.
• Prepare and maintain study documentation, including case report forms (CRFs), regulatory binders, study logs, questionnaires, and study closeout records.
• Assist with data analysis, reporting, quality assurance reviews, and internal audits to support study objectives and compliance requirements.
• Support the development and implementation of corrective and preventive action (CAPA) plans, when necessary.
• Coordinate participant reimbursement and study-related financial transactions.
• Mentor and provide guidance to research staff on protocol-specific procedures, study operations, and research best practices.
• Contribute to the development of standard operating procedures (SOPs), workflows, and process improvement initiatives.
• Monitor inventory and research supplies and coordinate procurement activities as needed.
• Promote a culture of patient safety, research integrity, inclusion, and respect through culturally responsive interactions with study participants and colleagues.
• Perform other related duties and responsibilities as assigned/requested.

Minimum Qualifications

• Bachelor’s degree and at least 3 years of relevant clinical research experience required, including in an academic medical setting.
• Demonstrated knowledge of clinical research regulations, human subjects protections, and research compliance requirements.
• Strong analytical, organizational, and critical-thinking skills with exceptional attention to detail.
• Proven ability to manage multiple priorities independently in a fast-paced environment while meeting deadlines.
• Excellent interpersonal, customer service, verbal, and written communication skills.
• Demonstrated commitment to ethical research conduct and professional standards consistent with organizations such as ACRP and SOCRA.
• Proficiency in Microsoft Office Suite, including advanced Excel skills.
• Ability to learn and effectively utilize new systems, databases, and research technologies.

Preferred Qualifications

• Professional certification through ACRP, SOCRA, or a comparable clinical research credentialing organization.
• Bilingual proficiency in English and Spanish.
• Experience coordinating complex clinical trials across multiple phases and study sponsors.
• Familiarity with Columbia University health and research systems.
• Educational background in a scientific, healthcare, public health, or business-related discipline.
• Experience with Epic, REDCap, Qualtrics, iLab, OpenSpecimen, or similar research management systems.
• Working knowledge of GCP, HIPAA, IRB processes, FDA regulations, and sponsor monitoring requirements.

Other Requirements

• Medical clearance and participation in the medical surveillance program
  • Contact with patients and/or human research subjects
• Successful completion of all required compliance and systems training

Equal Opportunity Employer / Disability / Veteran

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

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