Regulatory Coordinator

Grade 103

• Job Type: Officer of Administration
• Bargaining Unit:
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week: 35
• Standard Work Schedule:
• Building:
• Salary Range: $62,400 - $65,000
  
  

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 Section of Stem Cell Transplantation (SCT) at Columbia University Medical Center is recruiting for the position of a Regulatory Coordinator. The employee will work within the Division of Hematology, Oncology and Stem Cell Transplantation. The section of SCT has a cadre of Phase 1 and 2 trials, investigator initiated studies, and industry sponsored studies. The Regulatory Coordinator will be assigned to studies based on need and review of clinical trial roster. The Regulatory Coordinator will work with investigators, study staff, Scientific Review Committee (SRC) and institutional review boards (IRB), clinical trial sponsors and federal regulatory agencies to assure compliance with study protocols, data documentation, reporting requirements, ensure that regulatory requirements for clinical trials are met. The Regulatory Coordinator will work under the supervision of the Section Head, Divisional Administrator and CTO Program Manager.

At CUIMC, we are leaders in teaching, research, and patient care and are proud of the service and support we provide to our community. We apply the same rigor in our commitment to fostering an inclusive, thriving community and caring for our employees and their loved ones. We offer immediate eligibility and invest in our employees’ families through comprehensive Health and Welfare, Employee Assistance, Tuition Programs, and Retirement Benefits.

“Subject to business needs, we may support flexible and hybrid work arrangements. Options will be discussed during the interview process”

Responsibilities

• Determines compliance-required documentation and drafts necessary items such as protocols, informed consent, data security plans, etc.
• Ensures accuracy of IRB approval letters with respect to sponsor information and NIH grant identifiers.
• Determines and interprets applicable rules and regulations associated with clinical research studies and trials involving human subjects ensuring the protection of their safety, rights, and welfare.
• Guides and coordinates all associated submission, documentation, and reporting processes (new study applications, renewals, revisions, modifications, amendments, adverse events, safety reports, close-out, etc.) recommending alternatives to ensure compliance and approval.
• Acts as liaison between research staff (PI, faculty, nurses, technicians, etc.), and internal/external regulatory and oversight groups (NU's IRB, sponsors (NIH, industry), government agencies (FDA), etc.) to resolve issues and problems, negotiate compromises, and offer alternatives and recommendations to facilitate and expedite research while ensuring compliance.
• Provides guidance and training to research staff to ensure compliance with complex, highly specialized rules and regulations associated with clinical research studies and trials involving human subjects.
• Creates reports, summaries and analysis concerning compliance requirements recommending changes in practice or procedure to increase effectiveness and efficiency of compliance.
• Performs related duties & responsibilities as assigned/requested.
  
  

Minimum Qualifications

• Bachelor’s degree or equivalent in education and experience required.
  
  

Preferred Qualifications

• Two years of related experience.
  
  

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.