• Job Type: Officer of Administration
• Bargaining Unit:
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week: 35
• Salary Range: Commensurate with experience

Position Summary

The Clinical Research Core in the Department of Surgery is seeking an individual for the position of Clinical Research Coordinator (CRC) who will report directly to the Director and PIs. The main role of the CRC will be to operate and maintain the day-to-day operational duties of their assigned clinical trials and clinical research study database.

Responsibilities

• Clearly and effectively communicate with potential study subjects, clinicians, and other health care providers, ancillary staff, sponsors, and research office staff.
• Complete and maintain the required training for participation in clinical research, including but not limited to, Human Subjects Protection training and Clinical Research Coordinator Course.
• Work with Regulatory Coordinator in submitting new protocols, amendments, renewals and other regulatory bodies.
• Work with Program Coordinator in preparation of study budgets, submitting pharmacy cost estimates, ensuring compliance with research billing and processing stipends for subjects??? participation in studies.
• Coordinate day-to-day aspect of study related procedures, including, but not limited to scheduling visits and procedures, administration of study instruments, interpretation of study data, data entry, preparation for research visits, research visit documentation, maintenance of regulatory binders and study files, creation and/or maintenance of source documentation, and preparation for monitoring visits, site initiation/closeout visits and audits as needed.
• Rotate in an ???on call??? system for studies where research procedures are required on weekends or after hours.
• Prepare for, participate in, contribute to meetings with the Core, PIs, and sponsors.

Minimum Qualifications

• Requires a Bachelor's Degree or equivalent in education and 2 yrs of related experience.

Other Requirements

• Candidate will ensure integrity and compliance with all regulatory, institutional, and departmental requirements
• The ability to take initiative and work independently is required
• The ability to effectively work in a complex matrix is required
• Outstanding technical writing skills and understanding of medical terminology/research
• Advanced understanding of data management processes
• Ability to analyze and interpret scientific data and skilled in the use of computerized systems and databases
• Ability to understand and follow scientific research protocol and procedure
• Excellent communication skills (both verbal and written) required
• Exceptional organizational, interpersonal, and presentation skills
• Ability to understand and follow complex, detailed technical instructions
• Ability to foster a cooperative and collaborative work environment
• The ability to be flexible with scheduling is mandatory; willingness to work evenings and weekend hours in unusual or emergent situations required

Equal Opportunity Employer / Disability / Veteran

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