Job description

536049

Medical Center

Urology

Full Time

Opening on: May 13 2023

Grade 103

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Job Type: Officer of Administration

Bargaining Unit:
Regular/Temporary: Regular

End Date if Temporary:
Hours Per Week: 35

Salary Range: $65,000- $70,000

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.

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.

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