Clinical Research Coordinator 2, Non-Licensed

The Rector & Visitors of the University of Virginia
United States, Virginia, Charlottesville
1215 Lee Street (Show on map)
Nov 16, 2024
The Focused Ultrasound Center at the University of Virginia is seeking a highly motivated Clinical Research Coordinator. This position will manage the basic elements of clinical trial conduct and demonstrate a solid understanding of clinical research compliance. The successful candidate will be involved in most aspects of clinical research conduct and will continue to benefit from the opportunity to engage in additional on-the-job training and mentorship opportunities to continue to advance on the clinical research career path. Job Description Work closely with Principal Investigators and other study team members on all clinical research projects assigned. Become familiar with study start-up processes and requirements for: non-disclosure agreements, data use and material transfer agreements, clinical trial agreements, development of clinical trial budgets. Manage study recruitment and enrollment efforts including: screen and identify eligible patients, obtain and document informed consent and enrollment. Manage ongoing study conduct activities such as: schedule and coordinate study visits, maintain concomitant medication records, track and report adverse events, organize subject study payments. Collect and enter study data in a timely fashion, maintain corresponding documentation Collect, process, store and ship study specimens as needed. Assist in preparation, maintenance or creation of study documents such as: study visit schedules, study drug diaries, monitoring or training logs, equipment records or study communications. Prepare and submit all regulatory documentation to the IRB such as: personnel changes, annual protocol continuations, protocol modifications, adverse event reports, unanticipated events. Document and report protocol deviations. Reconcile study billing, identify charges covered by the study, versus charges to be billed to the subject/third party payor. Confirm Sponsor is invoiced for study activity. Notify PI and/or supervisor of any potential issues with the study or subject status. Communicate effectively with study Sponsor(s.) Proficient user of the various electronic platforms utilized in clinical research such as: IRB Pro, Protocol Builder, CRConnect, OnCore, e-regulatory platforms and Epic. Demonstrate a continuously increasing level of clinical research knowledge gained through active participation in training and mentorship opportunities as well as self-guided learning. In addition to the above job responsibilities, other duties may be assigned. Minimum Qualifications Education: Bachelor's Degree required or equivalent combination of experience, education and or certifications. Experience: At least one year of clinical research experience. Some experience in a healthcare setting and/or knowledge of medical terminology is preferred. Location: In-Person located in Charlottesville, VA. Anticipated Start Date: ASAP Position Type: This is an Exempt level, benefited position. Application Review Date: This position will remain open until filled. This position is a restricted position and is dependent upon project need, availability of funding and performance. The University will perform background checks on all new hires prior to employment. A completed pre-employment health screen is required for this position prior to employment. (Possibly a degree screening.) To Apply: Please apply through the UVA Job Board and search R0066652. Internal applicants must apply through their UVA Workday profile by searching 'Find Jobs'. Complete an application online with the following documents: CV or Resume Cover letter Upload all materials into the resume submission field, multiple documents can be submitted into this one field. Alternatively, merge all documents into one PDF for submission. Applications that do not contain all required documents will not receive full consideration. References will be completed via UVA's standardized process Skill Survey. A total of five references will be requested via SkillSurvey during the final phase of the interview process. For questions about the application process, please contact Jon Freeman, Recruiting Specialist, at jf2sw@virginia.edu For more information about UVA and the Charlottesville community please see http://www.virginia.edu/life/charlottesville and https://embarkcva.com/. The University of Virginia, including the UVA Health System which represents the UVA Medical Center, Schools of Medicine and Nursing, UVA Physician's Group and the Claude Moore Health Sciences Library, are fundamentally committed to the diversity of our faculty and staff. We believe diversity is excellence expressing itself through every person's perspectives and lived experiences. We are equal opportunity and affirmative action employers. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender identity or expression, marital status, national or ethnic origin, political affiliation, race, religion, sex, pregnancy, sexual orientation, veteran or military status, and family medical or genetic information.