Columbia University · 1 month ago
Clinical Research & Quality Assurance Manager - Nephrology
New York, NY
Full-time
Hybrid
Mid, Senior Level
$85K/yr - $125K/yr
4+ years expColumbia University is seeking a Clinical Research & Quality Assurance Manager for its Department of Medicine, Division of Nephrology. The role involves overseeing the operational, regulatory, and quality assurance aspects of human subjects research, including clinical trials and studies, while ensuring compliance with institutional and federal requirements.
EducationHigher EducationMedicalTrainingUniversities
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
Qualification
Required
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
Experience with Columbia's Research Administration System (RASCAL)
Familiarity with EPIC or other electronic medical record systems
Company
Columbia University
Columbia University is a research institution and Ivy League school for undergraduate and graduate students across various fields
10001+ employees
H1B Sponsorship
Columbia University has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (433)
2024 (353)
2023 (333)
2022 (370)
2021 (283)
2020 (221)
Funding
Current Stage
Late StageTotal Funding
$21.84MKey Investors
ValeNational Institutes of HealthNational Science Foundation
2024-09-24Grant· $0.02M
2023-08-17Grant
2023-05-04Grant· $20M
Leadership Team
Jeannette Wing
Executive Vice President for Research and Professor of Computer Science
Asaf Cidon
Assistant Professor, EE and CS
Recent News
Crain's New York Business
2025-12-11
Medical Xpress - latest medical and health news stories
2025-11-19
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