Reporting to the Clinical Research Manager and Principal Investigator (PI) in the Division of Digestive & Liver Diseases, the Clinical Research Coordinator will assist with initiation and implementation of endoscopic and gastroenterology clinical research studies. The studies will require flexibility with schedules including on call availability and working after hours and weekends.
Identify and screen potential subjects endoscopic and gastroenterology clinical research studies.
Coordinate all aspects of study visits, including scheduling visits and procedures.
Maintain detailed study files; monitor and report AE/SAE; and complete paper and/or electronic case report forms.
Ensure completion of protocol requirements, as well as data quality and integrity.
Responsible for processing and shipping laboratory specimens, and for stocking supplies.
Prepare for monitoring visits, sponsor visits, and audits.
Ensure compliance with research billing and process stipends for subjects.
Assist with submissions to IRB and other regulatory bodies.
Assist with maintenance of regulatory binders.
Create and maintain databases and perform statistical analysis of study data.
Performs additional related duties as needed
Bachelor's degree or equivalent in education, training and experience, plus three years of related experience
Experience with building and maintaining research databases, Redcap etc.
Experience with statistical analysis and programs, SASS etc.
Participation in the medical surveillance program
Contact with patients and/or human research subjects
Potential bloodborne pathogen exposure
Successful completion of applicable compliance and systems training requirements
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
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.