CLINICAL RESEARCH COORD B
Duties: The Clinical Research Coordinator will have direct patient interaction, including enrolling patients in studies. The research involves developing strategies to increase kidney and liver donation and utilization, while also optimizing outcomes for solid organ recipients. Research methods include retrospective data analyses and development of clinical trials in transplant care along with study management. However the main responsibility will be as the lead Clinical Research Coordinator for a clinical trial that will investigate the safety and efficacy of transplanting organs (kidneys, heart, and lungs) from hepatitis C-positive donors into hepatitis C-negative patients on the transplant waitlist, and then subsequently treating these patients with an investigational new hepatitis C drug (IND), following transplantation.
The CRC will organize, maintain, and submit all documentation for the assigned clinical research studies (including case report forms, source documentation, IND forms, regulatory and subject binders) as required by the Institution, sponsor and FDA. This individual will also collect/verify study related data; resolve sponsor data queries; assist in the submission of all regulatory documents to the study sponsor and the university's Institutional Review Board (IRB). The individual will work in a collegial environment, directly with a small team including physicians, research coordinators and students.
Qualifications: Bachelor's degree and 2-4 years of relevant experience or equivalent combination of education and experience required. The ideal candidate will have strong writing and editing skills; excellent interpersonal skills; attention to detail; creativity; and flexibility. Comfort in a medical setting, with handling confidential patient information, and with patient contact is a plus. Familiarity with the Microsoft Office Suite and general computer savvy is a must. Clinical trial experience with investigational drugs is preferred but not required, however prior clinical trial experience is required.
Reference Number: 40-28422
Salary Grade: 026
Employment Type: Exempt
Org: BE-Epidemiology Division
Job Family: I-Technical/Professional Research