• Job Type: Officer of Administration
• Bargaining Unit:
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week: 35
• Salary Range:

Position Summary

The Department of Pediatrics is seeking a Regulatory Coordinator to join our team in a full time position to work within the division of Hematology, Oncology and Stem Cell Transplantation in the section on Oncology. Columbia University Irving Medical Center’s Department of Pediatrics is a world leader in providing care for children. Our mission areas include Healthcare, Education and Research. We offer care for our patients in over 25 specialty areas as well as individualized care for complex cases. Our Residency, Fellowship and Graduate programs are among the best in the Nation. Our Clinical, Translational and Basic Science research features collaborations across specialties and stretches from the bench to bedside. We also have several active Clinical trials available to our patients. 

The employee will be a Columbia Officer and work within the Division of Hematology, Oncology and SCT. The section of SCT has a cadre of Phase 1 and 2 trials, investigator initiated studies, and industry sponsored studies. 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 of Oncology and the Divisional Administrator. 

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

Responsibilities

• Prepares and submits all protocol applications, amendments, continuing reviews, and informed consent documents for SRC and IRB review and approval.
• Prepares and submits regulatory documentation that may include; IND/IDE applications, FDA annual reports, Serious Adverse Event reports, to the appropriate regulatory agencies including the Food and Drug Administration (FDA) etc. 
• Prepares, maintains and organizes regulatory files for each assigned study in compliance with study sponsor requirements, PCFDTP etc. 
• Maintains various regulatory tracking databases with information related to study recruitment, subject enrollment, and study progress and completion. 
• Coordinates assigned study monitoring and auditing visits with study coordinator, investigator, industry sponsors, and internal/external auditors.

Clinical Trial Management: 

• Track and manage assigned new protocol start-up packet; initiate, facilitate and monitor study start-up progress. 
• Coordinate study agreements and budgets with Research Administration and the sponsor.
• Create and maintain tracking for all subsequent submissions to the SRC/IRB; protocol and consent amendments, all required safety reporting, all required deviations/violations, etc. 

Stakeholder Engagement: 

• Establish and maintain regular communication with study team, study sponsor, and applicable regulatory agencies to ensure all required information is communicated.
• Serve as facilitator for study team and sponsor with regard to study status information, safety issues, upcoming protocol amendments and consent changes and applicable protocol training. 

Leadership and Professionalism: 

• Maintain working knowledge of current regulations, regulatory guidance and or local policies.
• Assists DA and CTO Manager with regulatory based training and implementation of new or revised regulation, guidance and or local policy. 
• Present regulatory status updates at applicable research meetings
• Performs related duties & responsibilities as assigned/requested. 

Minimum Qualifications

• Bachelor’s degree or equivalent in education and experience required; plus two years of related experience.
• Minimum Education requirement (1.5 years of related experience for each year of education may be used to fulfill education requirements.) 

Preferred Qualifications

• Protocol oversight; monitoring and reporting of study events; data collection; adherence to study protocols; in-service education of physicians, nurses, and support staff to protocol requirements; coordinate research activities.

Other Requirements

Equal Opportunity Employer / Disability / Veteran

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