Responsible for collection, cataloging, coordination, processing, and quality control of clinical research data within the Department of Surgery. This includes pre- and post-research activities, internal and external to the clinical setting. Coordinate the implementation and compliance for multiple research data projects. Lead and take part in processing, analysis of online / electronic health record data and biospecimen requests, as well as queries of clinical databases for research projects. Maintain ongoing list of active investigators and projects utilizing clinical databases. Attend weekly meetings and proactively engage with investigators in support of research requirements and needs. Adheres to all organizational and other regulatory guidelines. Perform other related duties as assigned.
Collaborate with clinical and regulatory coordinators to document and report study enrollment, treatment, and follow-up into database
Review and synthesize information from medical records as specified by research protocol
Design, develop, test, and implement databases to support clinical research
Design and generate tracking and monitoring tools to enhance collaboration and improve efficiency of research data request fulfillment
Create and maintain technical documentation for all development activities
Document and analyze technical and user requirements
Ensure that all assigned projects and delivered within defined scope, quality, and time requirements
Regularly meet with team to discuss ongoing projects
Requires a bachelor's degree or equivalent in education and experience, plus two years of related experience in research and clinical study methodologies.
Strong written and oral communication skills and the ability to explain complex solutions in an easy-to-understand way
Experience with REDCap or similar electronic data collection systems is preferred
Working knowledge and understanding of regulatory environment in which clinical research occurs, including but not limited to ICH-GCP, 21 CFR, 45 CFR 46, HIPAA privacy rules, and similar
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Internal Number: 516214
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.