Clinical Research Coordinator III - PACC

Columbia University Irving Medical Center is hiring a Clinical Research Coordinator III to coordinate and administer complex clinical research studies and trials. The role independently manages day-to-day study operations, ensures regulatory and protocol compliance, and supports junior staff, monitoring, audits, and process improvement.

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

Preferred

• Prior clinical research experience in an academic medical center environment is strongly preferred
• 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
• Academic medical center experience
• ACRP/SOCRA certification
• English-Spanish bilingual proficiency
• Clinical trial coordination
• Multi-phase trial experience
• Multi-sponsor trial experience
• Columbia health systems familiarity
• Columbia research systems familiarity
• healthcare education
• Public health education
• Business-related education
• Epic
• REDCap
• Qualtrics
• iLab
• OpenSpecimen
• Research management systems
• Clinical Practice (GCP)
• HIPAA knowledge
• IRB processes
• FDA regulations
• Sponsor monitoring requirements

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 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
• Prior clinical research experience in an academic medical center environment is strongly preferred
• 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
• Bachelor’s degree and at least 3 years of relevant clinical research experience required, including in an academic medical setting.

Required skills

• ACRP Certification, Clinical Research, Clinical Research Regulations, English-Spanish Bilingual Proficiency, Epic, FDA Regulations, HIPAA, Human Subjects Protections, ILab, IRB Processes, OpenSpecimen, Qualtrics, REDCap, Research Compliance, SOCRA Certification

Preferred skills

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

Experience

• 3+ years