Clinical Research & Quality Assurance Manager - Nephrology

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

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.