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Regulatory Coordinator - Infectious Diseases

Medicine

Regulatory Coordinator - Infectious Diseases

  • 527946
  • Medical Center
  • Medicine
  • Full Time
  • Opening on: Jul 22 2022
  • Grade 104
  • Job Type: Officer of Administration
  • Bargaining Unit: n/a
  • Regular/Temporary: Regular
  • End Date if Temporary: n/a
  • Hours Per Week: 35
  • Salary Range: Commensurate with experience

Position Summary

Studies conducted at the Columbia P&S CRS include studies sponsored by the National Institutes of Health, investigator initiated studies as well as numerous industry studies in several areas: monoclonal antibodies for treatment and prevention of HIV, COVID-19, COVID-19 vaccine clinical trials, prevalence and implementation studies in area of COVID-19 and HIV.

Responsibilities

  • Responsible for protocol submission to relevant review committees including but not limited to the Columbia IRB.
  • Ensures that all regulatory files and protocol approvals are up-to-date.
  • Responsible for maintenance of regulatory documents and files in support of all research related protocols.
  • Manages communication with various departments and the IRBs.
  • Manages communication with the study sponsors around protocol registration, maintenance and close-out
  • Performs additional related duties as needed.

Minimum Qualifications

  • Bachelor’s degree or equivalent in education and experience, plus three years of experience
  • Excellent communication, writing and organizational skills
  • Computer proficiency
  • Orientation to detail with ability to maintain accurate records
  • Ability to handle multiple projects and interact with staff at all levels
  • Ability to work independently with minimal supervision

Preferred Qualifications

  • Knowledge of clinical research
  • Proficiency or fluency in Spanish

Other Requirements

  • Successful completion of applicable compliance and system training requirements

Equal Opportunity Employer / Disability / Veteran

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

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