Columbia University Regulatory Coordinator - Infectious Diseases in New York, New York
Requisition no: 508746
Work Type: Full Time
Location: Campus|Medical Center
Categories: Research (Lab and Non-Lab)
Job Type: Officer of Administration
End Date if Temporary: n/a
Hours Per Week: 35
Salary Range: Commensurate with experience
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 COVID-19, COVID-19 vaccine clinical trials, prevalence and implementation studies in area of COVID-19.
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.
Bachelor’s degree or equivalent in education and experience, plus three years of experience
Excellent communication, writing and organizational skills
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
Knowledge of clinical research
Proficiency or fluency in Spanish
- 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.