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