Clinical Research Coordinator Jobs

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

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:

• Implements research and administrative strategies to coordinate all aspects of clinical trials
• Oversees all aspects of the IRB protocol development process, including the submission of protocol, consent, and essential regulatory documents

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:

• Acts as a liaison between study participants and principal investigators, sponsors, and IRB
• Participates in routine audits for data quality, regulatory compliance, and subject safety reporting
• Assists in patient recruitment and retention, feasibility assessment, and budget development
• Maintains compliance with Columbia University policies and procedures, quality standards, and improvement initiatives
• 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.
• Prior experience using multi-institutional database management systems.
• Must be able to function independently and work collaboratively with all levels of personnel.

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.