• Job Type: Officer of Administration
• Bargaining Unit:
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week: 35
• Salary Range: $65,000- $70,000

Position Summary

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.

Responsibilities

Protocol Development: 

• 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

Financial Management: 

• 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

Quality Assurance: 

• 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

Data Management:

• Responsible for database management, upkeep, and producing data reports and analytics for faculty investigators
• Perform other tasks as assigned and requested

Minimum Qualifications

• Bachelor's degree or equivalent in education and experience, plus at least two (2) years of related experience.

Preferred Qualifications

• Experience with RedCAP, Access, SAS, SPSS.

Other Requirements

• 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.

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.

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