The Clinical Research Coordinator II will oversees all current clinical research projects in the Columbia Lung Transplant program, including 2 clinical trials with active enrollment and 2 longitudinal multi-center cohort studies.
Helps manage and coordinate clinical trials in compliance with federal regulations and internal policies.
Responsible for subject management and works closely with research team to facilitate screening, enrollment, and treatment of research subjects in compliance with established regulations and guidelines and internal standard operating procedures.
Assists with eligibility assessment and obtaining written informed consent as appropriate.
Maintains and disseminates accurate listings of active and potential study participants.
Functions as a liaison with sponsoring agencies and external sites.
Facilitates and helps lead research team meetings.
Facilitates sample collection, processing and storage activities.
Helps to prepare and oversee deviations and serious adverse events reports for the Institutional Review Board and other agencies.
Assists with regulatory submissions including protocol review and monitoring.
Provides training and mentorship to junior and new staff.
Assists with short term projects and provides cross coverage to various research team members as needed.
Attends conferences and disseminates information to clinical staff.
Performs other duties and responsibilities as needed.
Bachelor's degree or equivalent in education, training and experience, plus four years of related experience
RN or LPN degree, plus 4 years related experience
Clinical experience in the ICU or in ICU-related research
Five years of related experience
Participation in the medical surveillance program
Contact with patients and/or human research subjects
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.