Working collaboratively with Faculty Investigators, the Clinical Research Coordinator will be responsible for the day-to-day operations of the Clinical Research Unit.
Protocol Development: Oversee all aspects of the IRB protocol development process including protocol, consent and other essential study document drafting which will include the management and implementation of research and administrative strategies essential to the successful management of clinical trials research.
Financial Management: Works closely with the appropriate financial personnel, forecast trial resource needs, and assesses resource needs for program.
Clinical Trial Reporting: Generate protocol - status reports for key research personnel. Implements solutions for streamlining and accelerating the monitoring and review of clinical trials to significantly increase accrual to clinical trials, data cleaning, data quality, and trial completion; assisting the Investigators in all activities involved In NIH, investigator-initiated and pharmaceutical clinical research trials; ensuring compliance with protocols, GCPs, FDA regulations, commercial sponsor guidelines and standard operating procedure
Quality Assurance: participate in routine audits for data quality, regulatory compliance, patient safety issues related to clinical trial. Communicates and ensures compliance with Columbia University policies and procedures, quality standards and improvement initiatives. Assisting in recruitment and evaluation programs and budget development; liaison between patients and primary investigators, sponsors, and IRB; and assume responsibility and accountability in collaboration with the principal investigator and/or director for the case management of patients on research protocols.
Data Management: Responsible for all database management and upkeep. Produce reports and analytics for faculty investigators.
Bachelor's degree or equivalent in education and experience, plus at least two (2) years of related experience. Highly motivated, dependable, and detail oriented individual who can take creative initiative as needed. Individual must be able to function independently as well as work collaboratively with all levels of personnel. Prior experience using multi-institutional database management systems.
Experience with RedCAP, Access, SAS, SPSS, R strongly preferred.
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Internal Number: 509097
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.