Clinical Research Coordinator 2; Plastic Surgery

University of Virginia

1d•Onsite

About The Position

The Department of Plastic Surgery at the University of Virginia (UVA) School of Medicine is seeking candidates for a Clinical Research Coordinator 2, Licensed or Non-Licensed. This position coordinates and implements clinical trial research studies, works closely with the Principal Investigators, Operational Managers, and other research team members during the performance of the trials. The Department of Plastic Surgery research is directed by Dr. Scott Hollenbeck. Clinicians in the department lead several IRB supported prospective and retrospective clinical research efforts aimed at improving best practices through evaluating the efficacy of procedures and treatments. Candidates for this position will be involved in submitting and maintaining IRB protocols, consenting and enrolling patient subjects, maintaining enrollment databases, collecting objective data and patient reported outcomes, creating and maintaining clinical databases, data mining national databases, and other related activities. The Clinical Research Coordinator will report to Dr. Hollenbeck. UVA Plastic Surgery provides an environment where expertise and passions thrive, utilizing our extraordinary team of plastic surgeons, trainees, nurses and staff to advance patient care within UVA Health. With excellence in physician leadership, research, education and innovations, we strive to improve perioperative outcomes, establish unparalleled practices in patient care, and advance the field of plastic surgery globally.

Requirements

Bachelor's Degree Required or equivalent combination of experience, education and or certifications.
At least one year of clinical research experience.
Some experience in a healthcare setting and/or knowledge of medical terminology is preferred.
Licensed to Practice in Clinical Profession such as (but not limited to): Registered Nurse, Athletic Training, Pharmacology, Medical Technology, Physical Therapy or Registered Respiratory Therapy.

Nice To Haves

Regulatory experience.
Experience managing multiple clinical research studies simultaneously.
Proficiency in computer/automated systems for data purposes.
Effective use of Microsoft Office (Word, Excel, PowerPoint, and Outlook) and Microsoft OneDrive.
Strong organizational and planning tasks.
Excellent attention to detail.
Excellent verbal and written communication skills.

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.