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.
Internal Number: 508746
About Columbia University
Columbia University is one of the world's most important centers of research and at the same time a distinctive and distinguished learning environment for undergraduates and graduate students in many scholarly and professional fields. The University recognizes the importance of its location in New York City and seeks to link its research and teaching to the vast resources of a great metropolis. It seeks to attract a diverse and international faculty and student body, to support research and teaching on global issues, and to create academic relationships with many countries and regions. It expects all areas of the university to advance knowledge and learning at the highest level and to convey the products of its efforts to the world.