Columbia University Irving Medical Center · 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 Irving Medical Center is seeking a Clinical Research & Quality Assurance Manager to oversee the operational, regulatory, and quality assurance aspects of its human subjects research portfolio. The role involves supervising clinical research staff, ensuring compliance with regulatory requirements, and leading research operations to support the Division’s research mission.
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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 Irving Medical Center
Columbia University Irving Medical Center is a clinical and educational enterprise that offers medical, dental, and nursing services. It is a sub-organization of Columbia University.
10001+ employees
H1B Sponsorship
Columbia University Irving Medical Center 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 StageLeadership Team
D
Donna Lynne
Senior Vice President and COO
Recent News
2025-10-17
2025-10-06
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