The Neurologic Intensive Care Unit (NICU) research team in the Division of Critical Care and Hospitalist Neurology at Columbia University is looking for a Clinical Research Coordinator who will be responsible for the day-to-day operational duties of ongoing research projects in the NICU including coordination and administration of clinical trials.There will be an opportunity to work on mentored independent research projects and attend national conferences. This opportunity is ideal for individuals who will be applying for medical school or residency programs.
Collecting clinical and historical data on patients through medical chart review, recording of physiologic and neuroimaging data, and structured interviews with patients and family members.
Run weekly research meetings to discuss and adjudicate collected data.
Assume off hours and weekend coverage of on-going clinical trials screening and enrollment (two weeks per month).
Administratively and clinically manage clinical trials.
Adhere to Research SOP's.
Adhere to Good Clinical Practices and the study protocols.
Ensure scientific integrity of data and protect the rights, safety, and well-being of patients enrolled in clinical trials.
Discuss study protocols with patients and verify the informed consent documentation.
Provide patient with written communication of their participation (i.e. copy of the signed informed consent).
Meet with patient for each visit and maintain accessibility to discuss any questions/concerns regarding the study.
Schedule all patient research visits and procedures consistent with protocol requirements.
Complete and maintain case report forms per FDA guidelines, and review them against the patient's medical record for completeness and accuracy.
Administer questionnaires/diaries per protocol.
Ensure that non-serious and serious adverse events are properly documented and reported.
Ensure the filing and maintenance of all regulatory documents.
Schedule monitor visits and set up for monitoring visits prior to monitor's arrival.
Other duties as assigned.
Requires a bachelor's degree or equivalent in education, training and experience, plus two years of related experience.
Two years of related experience in clinical research.
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Internal Number: 508691
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.