Clinical Research Coordinator 2; Plastic Surgery at UVA Health

, Virginia, United States -

Full Time

Start Date

Immediate

Expiry Date

04 Jul, 26

Salary

0.0

Posted On

05 Apr, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical research, IRB protocol management, Patient consenting, Data management, Regulatory compliance, Medical terminology, Study recruitment, Adverse event reporting, Clinical trial budgeting, Electronic data capture, Epic, OnCore, Protocol builder, Microsoft Office, Organizational skills, Communication skills

Industry

Hospitals and Health Care

Description

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. 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 REQUIREMENTS Clinical Research Coordinator, 2 Non-Licensed 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. Licensure: None. Clinical Research Coordinator, 2 Licensed Education: Bachelor's Degree Required or equivalent combination of experience, education and or certifications. Nursing Diploma may substitute for Degree for Licensed Registered Nurse. Experience: At least one year of clinical research experience. Licensure: 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. PREFERRED QUALIFICATIONS 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. PHYSICAL DEMANDS This is primarily a sedentary job involving extensive use of desktop computers. The job does occasionally require traveling some distance to attend meetings, and programs. Salary will be commensurate with education and experience. This is an exempt-level, benefited position. Learn more about UVA benefits. This position is based in Charlottesville, VA, and must be performed fully on-site. About UVA and the Community To learn more about UVA and in the Charlottesville area, visit UVA Life and Embark CVA. Additional Requirements Background checks, pre-employment health screenings, and drug screenings will be conducted on all new hires prior to employment. How to Apply Please apply online, by searching for requisition number R0081765. Complete an application with the following documents: Resume Cover Letter Upload all materials into the resume submission field. You can submit multiple documents into this one field or combine them into one PDF. Applications without all required documents will not receive full consideration. Internal applicants: Search and apply for jobs on the UVA Internal Careers website. Reference Check Process Reference checks will be completed by UVA’s third-party partner, SkillSurvey, during the final phase of the interview. Five references will be requested, with at least three responses required. Contact For questions about the application process, please contact Jeremy Brofft, Senior Academic Recruiter at xmf9ad@virginia.edu. The University of Virginia is an equal opportunity employer. All interested persons are encouraged to apply, including veterans and individuals with disabilities. Learn more about UVA’s commitment to non-discrimination and equal opportunity employment.

Responsibilities

The Clinical Research Coordinator will manage and implement clinical trial research studies, including IRB protocol maintenance and patient enrollment. They will also collect and manage study data, coordinate study visits, and ensure regulatory compliance throughout the research process.