Clinical Research Coordinator 2, Non-Licensed, Orthpaedic Surgery

State of Virginia • Charlottesville, VA

103d

About The Position

Clinical Research Coordinator-2, Non-Licensed (CRC-2, NL), is a role that requires some previous experience in clinical research. A CRC 2 will be able to manage the basic elements of clinical trial conduct and demonstrate a solid understanding of clinical research compliance. CRC2 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. A CRC2 works under the moderate supervision of a Principal Investigator and/or an experienced CRC and will manage a reasonable portfolio of clinical trials or research projects as assigned by a supervisor. The University of Virginia's Department of Orthopaedic Surgery is seeking applicants for a Clinical Research Coordinator 2 (Non-Licensed) to join its clinical research team. Applicants should possess an understanding of clinical trials, and have at least one year's experience in clinical research. The selected candidate will manage multiple clinical trials, and demonstrate a solid understanding of clinical research compliance.

Requirements

• 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.
• Previous CRC experience of 2 years is preferred.
• Training in Good Clinical Practices (GCP) and management of clinical trials is required.
• Proficiency with Microsoft Office including Word, Excel, Power Point, and Outlook.
• Experience in clinical research budgets and billing are preferred along with experience with electronic data capture reporting.

Responsibilities

• 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.

Benefits

• Commensurate with candidate's experience and qualifications, with UVA benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Executive, Legislative, and Other General Government Support
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees