Clinical Research Coordinator 2, Non-Licensed, Orthopaedic Surgery

Benefits

Qualifications

• •Bachelor's degree and an additional one year of experience is required
• •Four years of experience with a Clinical Research Coordinator (CCRC) license and/or Clinical Research Associate (CCRA) license will substitute for a degree
• •Training in Good Clinical Practices (GCP) and management of clinical trials is required as well as proficiency with Microsoft Office, including Word, Excel, PowerPoint, and Outlook
• •Anticipated hiring range: Commensurate with candidate's experience and qualifications, with UVA benefits
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Responsibilities

• •The Clinical Research Coordinator 2 (Non-Licensed) will manage multiple clinical trials, demonstrating a solid understanding of clinical research compliance
• •The selected candidate will work closely with Principal Investigators and other study team members, manage study recruitment and enrollment efforts, and collect and enter study data in a timely fashion
• •Work closely with Principal Investigators and other study team members on all clinical research projects assigned
• •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 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
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