Reporting to the Director, responsibilities include coordination of research protocols with Principal Investigators and co-investigators, developing, updating, and executing clinical protocols. The coordinator will complete IRB submissions and updates/revisions using a web-based IRB submission system and communicating with IRB personnel for clarification as needed. Protocols range from investigator-initiated studies to industry- or NIH-sponsored clinical trials.
The coordinator will be responsible for patient recruitment, screening, track paperwork and consent forms, assess inclusion and exclusion criteria, work with related clinical services, and arrange for specimen collection. The coordinator may also be involved in aspects of clinical care such as breath testing at the Celiac Disease Center. S/he must be able to handle several tasks at once, possess extreme attention to detail and meet strict deadlines.
Monitor vital signs including blood pressure, pulse, and heart rate, measuring BMI, ensuring that all vital signs are within acceptable ranges prior to dose administration.
Obtain biospecimens such as blood samples during subject screening and as needed during experimental protocols.
Responsible for handling all laboratory specimens (processing and shipping samples), and documenting laboratory data.
Administer study medications to participants as needed during experimental protocols (in coordination with the research pharmacy).
Organize and supervise experimental protocols: setting up computers prior to the start of experimental sessions, carefully monitoring participants during sessions, and ensuring accurate data collection.
Ensure that research subject files are accurate and up to date, consulting with responsible physicians and investigators as needed.
Perform reminder phone calls for research subject appointments.
Assemble, send, and receive study packets.
Assemble charts with all appropriate measures, labeling them with study ID's and making them available on study day.
Maintain the inventory of recruitment pamphlets, consent/HIPAA forms, and other study documents.
Enter and validate data in a web-based data system (in concert with the study sponsor).
Maintain all the regulatory documents related to the study renewals, amendments, serious adverse events and all other documents required by the IRB, the sponsor and the FDA.
Report all changes and regulations to a monitor from the sponsor on a monthly basis.
Act as a liaison between the sponsor, trial monitors, and the PI.
Perform other duties as needed.
Bachelor's Degree or equivalent in education and experience, plus three years related experience
Phlebotomy skills or ability to successfully complete phlebotomy skills training
Previous experience with major, multifaceted projects with a broad range of participants and functionality
Excellent information management, analytical, administrative, and organizational skills
Ability to exercise sound judgment while being sensitive to the protocol guidelines and parameters
Excellent interpersonal, as well as strong team management skills
Hands-on experience with PC software for word processing, spreadsheets and/or statistical software
Ability and willingness to work in a fast-paced research environment
Excellent time management skills, with ability to work independently as well as collaboratively
Strong communication skills including written and verbal
Familiarity with GCP, IRB and FDA regulations
Successful completion of applicable systems training requirements
Participation in the medical surveillance program
Contact with patients and/or human research subjects
Potential bloodborne pathogen exposure
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Internal Number: 513853
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.