The Department of Biomedical Informatics is seeking an individual for the position of Clinical Research Coordinator (CRC) who will report directly to the Director of Clinical Informatics for the Institute for Genomic Medicine. 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.
Maintenance of detailed study files and complete paper case report forms and uploading of electronic case report forms/data within 48 hours of collection
Obtain fully informed consent of all eligible trial and study patients in accordance to IRB, local and federal statutes
Clear and effective communication with potential study subjects, clinicians, other health care providers, ancillary staff, and research office staff.
Completion and maintenance of the required training for participation in clinical research, including but not limited to: mandatory regulatory training, protocol specific training, ancillary required training per protocol/CUMC
Collect, process, and assist in the compilation and verification of research data, samples, and/or specimens (following strict protocol and detailed instructions); data is collected through medical chart review, recording of physiologic, imaging data, structured interviews with patients and family members, and conducting all follow up visits in strict accordance with protocol specifications
Working with regulatory coordinator in submitting new protocols, amendment, renewals, and other regulatory submissions to IRB, sponsor, FDA, and other regulatory bodies.
Working with Research Director as needed in:
Coordination of day to day aspects of study related procedures, including, but not limited to: scheduling study subject 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.
Handling & processing of human bio-specimens such as blood, saliva, tissue, and stool.
Participation in an "on call" system for studies where research procedures are required on weekends or after hours.
Bachelor's Degree or equivalent in education and experience, plus two years of related experience. This opportunity is ideal for individuals who will be applying to residency, foreign medical graduates, or individuals with a graduate health sciences degree or undergraduate health sciences degree.
Essential Functions: Working knowledge of MS Office, specifically Word and Excel is required. Experience with statistical analysis programs (ie. SAS, SPSS, STATA) is preferred.
General skills: Qualifications for Candidates include but are not limited to the following:
Candidate will ensure integrity and compliance with all regulatory, institutional, and departmental requirements
The ability to take Initiative and work independently is required, and 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 & 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.
Internal Number: 502847
About Columbia University
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.