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

Position Summary

The Transplant Clinical Research Center (TCRC) in the Department of Surgery is seeking an individual for the position of Clinical Research Coordinator (CRC) who will report directly to the Associate Director of the Transplant Clinical Research Center. The main role of the CRC will be to operate & 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, amendment, renewals and other regulatory bodies
• Work with Program Coordinator in preparation of study budget, submitting pharmacy cost estimates, ensuring compliance with research billing and processing stipends for subject???s participation in studies.
• Coordinate day-to-day aspect of study relayed procedures, including, but not limited to scheduling visits and procedures, 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 reach procedures are required on weekends or after hours.
• Prepare for, participate in, contribute to meetings with the TCRC, PIs, and sponsors.
• Processing of specimens for trials as required per study specific protocols.

Minimum Qualifications

• Bachelors degree or equivalent in education and training plus two years experience required.

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 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 & 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.