Regulatory Coordinator - Infectious Diseases

Regulatory Affairs Coordinator

The Columbia University Division of Infectious Diseases is seeking a Regulatory Affairs Coordinator to join its research team. The candidate will provide regulatory oversight and support for clinical research related regulatory matters at the Columbia P&S Clinical Research Site (Columbia CRS). 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 : treatment and prevention of HIV, sexual health and other infectious diseases of public health importance, as well as community-based and implementation studies in area of COVID-19, HIV, sexual health etc. This position presents opportunities for professional development.

Responsibilities :

• Coordinate protocol submission to relevant review committees including but not limited to the Columbia IRB
• Ensure that all regulatory files and protocol approvals are up-to-date
• Maintain regulatory documents and files in support of all research related protocols
• Communicate with various departments and the IRBs
• Communicate with the study sponsors around protocol registration, maintenance and close-out
• Assist with development of standards operating procedures and study materials
• Work with clinical and laboratory staff to support study implementation and study conduct

Candidate will perform additional related administrative duties as assigned to support study success

Minimum Qualifications :

Preferred Qualifications :

Other Requirements :

Equal Opportunity Employer / Disability / Veteran Columbia University is committed to the hiring of qualified local residents.