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Regulatory Coordinator

Pediatrics

Regulatory Coordinator

  • 532864
  • Medical Center
  • Pediatrics
  • Full Time
  • Opening on: Dec 17 2022
  • Grade 103
  • Job Type: Officer of Administration
  • Bargaining Unit:
  • Regular/Temporary: Regular
  • End Date if Temporary:
  • Hours Per Week: 35
  • Salary Range: $58,500-$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 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 & Stem Cell Transplantation. 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. This position will support the department by providing regulatory/compliance oversight to clinical trials.

"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.
  • 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. 
  • Ensure various regulatory reporting requirements are met by the sponsor, FDA, IRB 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.

Preferred Qualifications

  • Experience handling protocol oversight; monitoring and reporting of study events; and data collection.

  • Experience monitoring adherence to study protocols; providing in-service education of physicians, nurses, and support staff to protocol requirements.

  • Ability to coordinate research activities.


Equal Opportunity Employer / Disability / Veteran

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

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