The Columbia Center for Translational Immunology (CCTI) at Columbia University Irving Medical Center (CUIMC) is seeking a highly motivated and talented Clinical Research Coordinator to join our team. The main topic of this research is a pilot clinical trial using Tâ€�cell alloreactivity and chimerism to guide immunosuppression minimization in intestinal transplantation. Primary responsibilities include consenting patients and collection of clinical specimens and data before and after organ transplantation.
Identify, recruit, and consent eligible participants; conduct visits as outlined in study protocols and in accordance with Good Clinical Practices (GCP) and HIPAA guidelines.
Perform researchâ€�related services including coordinating and scheduling study visits, and making telephone calls.
Responsible for data collection, entry and transmission; specimen collection, processing, storing and shipping.
Collect, transport, process and shipping blood, lymphoid tissue, intestinal tissue, bone marrow and stool samples in accordance with federal, state and institutional policies, as well as delineated in sponsor's protocol.
Interface with various hospital departments including medical records, radiology, nursing, information technology services, and others as needed.
Coordinate the collection of all research data points as assigned through research visits, chart abstraction or telephone.
Consult with EPIC medical records and UNOS organ donor database to obtain pertinent information of patient and the donor, including age, sex, HLA typing, immunosuppression regimen, rejection and infection episodes, DSA development, and onset of other clinical complications.
Perform venipuncture as needed in the collection of blood samples using standard sterile technique.
Ensure the appropriate tests, procedures and laboratory tests are completed. Ensure all relevant clinical staff are informed of research participation.
Ensure regulatory documents and administrative files for each protocol are up to date. Create and maintain patient research records and enter research data into a centralized database program and other study specific electronic databases.
Attend and participate in Investigator, site initiation and monitoring meetings as assigned.
Report to the Principal Investigator and Human Studies Research Manager of the CCTI within the Department of Medicine at Columbia University.
Adhere to assigned research protocols and manual of operation set forth by the sponsor, maintain screening and randomization logs and handle correspondence appropriately.
Responsible for participating in onâ€�call activities to cover research activity offâ€�hours.
Perform other related duties as needed.
Bachelor's degree or equivalent in education, training and experience, plus two years of related experience
Experience in Clinical Research and Patient Care Setting
Excellent interpersonal skills, written, verbal, organizational and communication skills
Possess and maintain a Phlebotomy certification
Selfâ€�directed and able to make independent decision within the parameters of all federal, state, institutional and departmental guidelines
Detail oriented and able to multiâ€�task.
Selfâ€�motivated with ability to work independently as well as part of a team
Proficiency with Microsoft Word, Excel, PowerPoint and data management files required
Bachelor's degree or equivalent in healthcare, life sciences, medical technology, or related fields
Qualified to take examination for ACRP or SOCRA certification
Contact with patients and/or human research subjects
Potential bloodborne pathogen exposure
Participation in the medical surveillance program
Successful completion of applicable compliance and systems training requirements
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Internal Number: 515070
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