The Division of Rheumatology is seeking a Clinical Research Coordinator I to provide support for the Columbia University Irving Medical Center Rheumatology Clinical Research group. The Clinical Research Coordinator I will report to the Chief and the Administrator within the Department of Medicine, Division of Rheumatology. The CRC I will provide administrative support for multiple research studies (government, private and pharmaceutical) within the division through the coordination and implementation of clinical trials and protocols involving human subjects.
Work with the Clinical Research Directors, PIs, and Research Nurses to oversee the day-to-day activities of the complex clinical research operations of the Division of Rheumatology.
Responsible for screening and randomizing subjects for clinical research studies.
Track and follow-up with study participants.
Monitor all aspects of quantitative data collection.
Responsible for coordination of clinical and research data collection, quality assurance, analysis and preparation.
Draft IRB protocol and materials, monitor IRB status, maintain IRB approvals and ensure seamless communication with the IRB on all matters related to the protocol.
Contribute to trial budget preparation and review.
Establish schedules, as well as recruitment and participant interviewing procedures.
Write reports and assist in drafting manuscripts and papers.
Write proposals and plan prospective studies.
Oversee and help supervise clinical research coordinators ensuring appropriate coverage for research study visits.
Responsible for on-boarding and training newly hired coordinators.
Take an active role in the teaching of rules, policies, procedures and systems to new hires in order to ensure successful navigation of their own research projects.
Supervise clinical research coordinators to ensure safety of all study participants.
Help establish a cohesive research team through monthly meetings and ongoing collaboration/communication for the entire division where all coordinators can come together to share best practices, standard operating procedures and knowledge.
Assist the Division Administrator with monitoring compliance including JCAHO, CUMC/NYP, and Environmental Health and Safety requirements.
Perform additional related duties as needed.
Requires bachelor's degree or the equivalent in training, education and/or experience plus three years of clinical research and/or nursing 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.
Internal Number: 510505
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