The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.
Working collaboratively with Principal Investigators and the Research Manager, the Clinical Research Coordinator will be responsible for the day-to-day operations of research activities within the Department of Urology.
Oversees all aspects of the IRB protocol development process, including the submission of protocol, consent, and essential regulatory documents
Implements research and administrative strategies to coordinate all aspects of clinical trials
Works closely with appropriate financial personnel to forecast clinical trial resource needs and anticipates resource requirements for the research program
Clinical Trial Reporting:
Generates protocol status reports for principal investigators and key research personnel
Implements strategies to streamline and accelerate the monitoring of ongoing clinical trials to significantly increase subject accrual, data entry and cleaning, data quality, and successful completion of trials
Monitors and reviews research activities involved with NIH-funded, investigator-initiated, pharmaceutical, and investigational device clinical trials
Ensures compliance with study-specific protocols, standard operating procedures, FDA/GCP and ICH guidelines, and commercial sponsor regulations
Participates in routine audits for data quality, regulatory compliance, and subject safety reporting
Maintains compliance with Columbia University policies and procedures, quality standards, and improvement initiatives
Assists in patient recruitment and retention, feasibility assessment, and budget development
Acts as a liaison between study participants and principal investigators, sponsors, and IRB
Communicates proactively with the principal investigator and program director for case management of subjects on research protocols
Responsible for database management, upkeep, and producing data reports and analytics for faculty investigators
Perform other tasks as assigned and requested
Bachelor's degree or equivalent in education and experience, plus at least two (2) years of related experience.
Experience with RedCAP, Access, SAS, SPSS.
Highly motivated, dependable, and detail-oriented individual who can take the creative initiative as needed.
Must be able to function independently and work collaboratively with all levels of personnel.
Prior experience using multi-institutional database management systems.
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
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.