Advertised Summary Job Description: The Division of Rheumatology is currently seeking a highly motivated clinical research nurse with extensive clinical research experience to support the coordination and management of clinical trials and studies. One half to two thirds of the nurse's time will be spent in the Lupus Center working with the Clinical Director of the Center on lupus clinical trials and the care of lupus center patients. The remaining time will be spent working with other physician investigators in the Division on clinical trials/studies in patients with other autoimmune illnesses.
The coordinator will be primarily responsible for all aspects of protocol management, including the recruitment of study subjects, screening for subject eligibility and enrolling patients according to research protocols, data collection and analysis, protocol compliance, laboratory and specimen submission for processing, maintenance of accurate and complete clinical research files and case report forms, and the preparation of regulatory documents for Institutional Review Board submissions. In addition, the coordinator must maintain adequate inventory of study drugs and supplies, prepare budgets, and maintain financial records pertaining to studies.
The coordinator must be able to perform study related procedures without direct supervision by the PI or Co-PI. The coordinator will be tasked with supervising, training and evaluating research data associates, student volunteers, and assign specific research activities to the research staff. In addition, the coordinator will work alongside physicians and other healthcare professionals in the rheumatology program to provide healthcare and coordinate the care of patients. The coordinator will act as a liaison between investigators, sponsor and the IRB.
Other duties will include the following. Supervise clinical research coordinators to ensure safety of patients enrolled in research studies. Administer FDA approved and experimental intravenous and injectable biologic therapies for patients participating in research studies of such agents. Educate non-Rheumatology research nurses as needed regarding rheumatological procedures and therapies needed for the conduct of research studies. Liaison with clinical and research pharmacists. Given the opportunity, participate in community and/or peer presentations, and author or co-author publications related to areas of expertise.
General Minimum Qualifications: Requires Master's degree or equivalent in education and experience, plus one to two years of experience. A current New York State NP and RN license required.
Additional Specific Minimum Qualifications: Stellar clinical, interpersonal and communication (both written and verbal) skills required. Understanding of clinical research activities and guidelines related to consent, ethical conduct, and protection of human subjects. Incumbent must demonstrate leadership skills and must possess the ability to maintain patient confidentiality, and to collect, record, transcribe, and synthesize clinical data.
Preferred Qualifications: Pharmaceutical and industry sponsored trial knowledge is preferred. Fluency in Spanish preferred. Extensive clinical research experience 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.