Advertised Summary Job Description: The Department of Otolaryngology/Head and Neck Surgery is seeking a Clinical Coordinator I to provide support in all responsibilities related to government/private and pharmaceutical clinical research studies/trials. Duties of the Clinical Coordinator I 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.
The Clinical Coordinator I 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.
General Minimum Qualifications: Requires a bachelor's degree in biological sciences or equivalent in education, training and experience, plus three years of related experience.
Additional Specific Minimum Qualifications: 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. Experience with Rascal and Study Manager preferred.
As a member of the National Collegiate Athletic Association (NCAA) and the Council of Ivy Group Presidents (Ivy League), it is imperative that members of the Columbia University community, in all matters related to the intercollegiate athletics program, exhibit the highest professional standards and ethical behavior with regard to adherence to NCAA, Conference, University, and Department of Intercollegiate Athletics and Physical Education rules and regulations.
Columbia University is an Equal Opportunity/Affirmative Action employer.
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.