• Job Type: Officer of Administration
• Regular/Temporary: Regular
• Hours Per Week: 35
• Salary Range: $85,000 - $125,000

Position Summary

The Department of Medicine, Division of Nephrology seeks a Clinical Research & Quality Assurance Manager to oversee the operational, regulatory, and quality assurance aspects of its human subjects research portfolio. This includes pharmaceutical-sponsored international clinical trials, federally funded studies, genetics research, and related sub studies. The Manager will serve as the primary liaison for all IRB-regulated research initiated by Division faculty and ensure compliance with institutional, federal, and sponsor requirements.

Reporting to the Division Administrator and working closely with Principal Investigators (PIs), Clinical Research Coordinators (CRCs), and other stakeholders, the Manager will lead research operations, regulatory submissions, and quality assurance activities to support the Division?s research mission.

Responsibilities

• Supervise and manage clinical research staff, including performance evaluations, time-off tracking, and professional development.
• Serve as the primary point of contact for incoming research protocols, budgets, and contracts; assist PIs with feasibility assessments and sponsor communications.
• Coordinate registration of clinical trials with the Clinical Trials Office (CTO); collaborate with budget analysts and contract specialists.
• Facilitate pricing and approvals for ancillary services (e.g., Research Pharmacy, Pathology); ensure timely submission to budget analysts.
• Lead IRB submissions and maintain regulatory compliance throughout the study lifecycle (initial submission, amendments, renewals, closures).
• Maintain Investigator Site Files (ISFs) and regulatory documentation in audit-ready condition.
• Conduct periodic QA reviews of CRC documentation and source binders.
• Oversee protocol-specific training and remediation for research staff.
• Ensure completion of institutional training requirements (Human Subjects Protection, HIPAA, GCP, COI) for all research personnel.
• Schedule and coordinate site visits, monitoring visits, and audits; ensure vendor credentialing compliance for external visitors.
• Prepare quarterly financial reports and ad hoc research activity reports for Division leadership.
• Serve as backup to the Nephrology Data Analyst, including data entry in REDCap and participation in weekly research meetings.
• Manage research supply inventory and procurement.
• Perform additional related duties as needed or assigned.

Minimum Qualifications

• Bachelor?s degree or equivalent combination of education and experience.
• Minimum of four (4) years of experience in clinical research or related healthcare setting.
• Demonstrated experience in regulatory compliance, quality assurance, or project management.
• Proficiency in REDCap.
• Strong interpersonal skills and ability to collaborate across teams and levels.
• Strong organizational and multitasking skills in a dynamic environment.
• Excellent communication and customer service orientation.

Preferred Qualifications

• Experience with Columbia?s Research Administration System (RASCAL).
• Familiarity with EPIC or other electronic medical record systems.

Other Requirements

• Flexibility to work extended hours and occasional weekends to meet deadlines.
• Commitment to equity, diversity, and inclusion.
• 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.

About Columbia University

Columbia University is one of the world's most important centers of research and at the same time a distinctive and distinguished learning environment for undergraduates and graduate students in many scholarly and professional fields. The University recognizes the importance of its location in New York City and seeks to link its research and teaching to the vast resources of a great metropolis. It seeks to attract a diverse and international faculty and student body, to support research and teaching on global issues, and to create academic relationships with many countries and regions. It expects all areas of the university to advance knowledge and learning at the highest level and to convey the products of its efforts to the world.

Connections working at Columbia University