The Department of Otolaryngology/Head and Neck Surgery is seeking a Clinical Research Coordinator to provide support in all responsibilities related to government/private and pharmaceutical clinical research studies/trials.
Duties of the Clinical Research Coordinator will include: identifying, screening and assessing subjects for study; tracking study subjects against the protocol, and recording this information in Study Manager; analyzing and preparing data, writing reports and assisting in drafting manuscripts and papers. The incumbent will be fully trained and certified in IRB regulations required for this position. This position reports to the Department Administrator.
The Clinical Research Coordinator participates in patient education, obtaining informed consent, ordering pre-randomization tests and dispensing and ordering study drug
Conducts follow-up evaluations both inpatient and outpatient, including monitoring of safety data; assuring compliance with study protocol; and maintaining case report forms
Interacts with the Institutional Review Board (IRB) and Institutional Animal Care and Use Committee (IACUC)
Responsible for retrieval and entry of data from study site
Reviews and extracts data from patient charts
Assists with preparation of data for statistician and develops ongoing reports for Principal Investigator (PI), statisticians and DSMB
Performs other related duties as assigned
Bachelor's degree or equivalent in education and experience, plus three years of related experience
Experience with Rascal and Study Manager preferred
Bachelor's degree in biological sciences
Excellent verbal and written communications skills and attention to detail required
Computer skills (Microsoft Office suite) required. Must be able to work independently and must strictly adhere to deadlines and protocols
Good Clinical Practices (GCP) and HIPAA certification required
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Internal Number: 514685
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.