Clinical Research Operations Associate, Physician Assistant/Nurse Practitioner
Center for Diabetes Technology (UVA)
Job ID: R0040042 | Clinical Research | Full Time | Charlottesville, VA
The UVA Center for Diabetes Technology seeks a Clinical Research Operations Associate, Physician Assistant/Nurse Practitioner. The Clinical Research Operations Associate is responsible for supporting services for clinical research studies, including following the direction of all physicians working on clinical research studies, within the scope of licensing, training, and credentialing, dependent on specialty. This position will not involve any clinical patient care and the expertise of this employee will only be involved in research projects and programs.

The CDT is directed by Boris Kovatchev, PhD, a world-renowned researcher in the field of diabetes, algorithm development, and data science. Dr. Kovatchev is a regular lecturer at universities and conferences throughout the US and Europe. With substantial NIH funding, the Center led and successfully completed the three largest randomized artificial pancreas (AP) clinical trials in the world to date, including a pivotal trial aiming for regulatory clearance of a new artificial pancreas system (that included the algorithm program developed at the Center), published in the New England Journal of Medicine.

The successful applicant will be expected to:
  • Assist physicians and Operations team with all activities involving interactions with Research and clinical study subjects/participants. Participate as a major contributor to Research study execution, focusing attention with clinicians and clinical research coordinators and their daily activities.
  • Perform all study responsibilities in compliance with the approved protocol.
  • Document all findings in participant-specific source documents.
  • Provide ongoing assessment of the study participants to identify adverse events and device-related issues.
  • Provide medical management of adverse events as appropriate.
  • Communicate with sponsors, auditors, monitors, and DSMB as requested.
  • Possess a working knowledge of GCP/ICH guidelines, Research SOPS, and QA/QC procedures.
  • Participate in on-call activities as required to assure adequate medical coverage.
  • Educate participants and care partners on the research study and respond to participant inquiries.
  • Effectively communicate and collaborate within a research team composed of physicians, scientists, clinical research coordinators, data managers, registered nurses, technicians, students, and other members of the Center.
  • Collect medical history, ECGs.
  • Physical exam, specimen collections, and diagnostic assays.
  • Collect vital signs: body temperature, respirations, heart rate, etc.
  • Provide staff and study participant education.
  • Review and adjust participant's diabetes mellitus medical management, including therapeutics, insulin pump therapy, and use of continuous glucose monitors during study participation.
  • Provide support services for all physicians, administrative management, clinical research coordinators, and other interprofessional research team members to facilitate clinical research studies.
  • Exercise professional judgment and expertise to support the operations, primarily in support of the physicians working on clinical research studies.
  • Assist physicians working on clinical research studies with all aspects of a clinical research study; identify issues for discussion with physicians and with other research staff; and document and clearly communicate with other clinical research staff, including with faculty, principal investigators, and management.
  • Perform procedures within scope of clinical research study guidelines as may be outlined by the FDA, IRB, or DSMB bodies in relation to good practice for clinical research trials.
  • Assist physicians and other research staff with understanding or necessary supplies for clinical research studies.
  • Provide information, education, and support to clinical study subjects (and family members as appropriate) as may be directed by the physician assigned to the clinical research study.
  • Meet quality standards for clinical research studies as determined by the physician and principal investigator.
  • May participate in the clinical research study education and training programs for students (graduate/postgraduate advanced practice and research staff, as appropriate).
  • Participate in group research study meetings and other review activities as requested.
  • Prepare reports and correspondence necessary or appropriate to the performance of tasks related to clinical research studies.
  • Follow policies and procedures for good practice of clinical research trials as determined by regulatory bodies.
  • Update practice through continuing education by attending conferences, reports, lectures, journal clubs, and regional/national professional conferences.
  • Seek professional development and growth opportunities that enhance professional practice through formal and informal activities, including developing and presenting educational programs.
  • Perform other duties as assigned that are commensurate with professional service normally and customarily provided by a licensed independent provider.

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.

Qualified candidates must have:
  • Education: Graduate of an accredited graduate school of nursing or physician assistant program with a master's degree.
  • Experience: 1 year of clinical experience in area of expertise.
  • Licensure: License or license eligibility as an Advanced Practice Provider (Nurse Practitioner, Physician Assistant, Certified Registered Nurse Anesthetist, and Certified Nurse Midwife) as set forth by the state of Virginia. If Nurse Practitioner, license to practice as a registered nurse in the Commonwealth of Virginia is required. Must demonstrate and maintain all credentialing and licensing requirements of UVA Health System, the Virginia Board of Medicine or the Virginia Board of Nursing, and appropriate certifying bodies. Current Basic Life Support (BLS) required. Current PALS/NRP, as required specific to position. Advanced Cardiac Life Support (ACLS), as required specific to position.

Preferred experience:
  • Experience in the treatment and management of T1 and T2 diabetes mellitus, including therapeutics, insulin pump therapy, and continuous glucose monitors.
  • Experience in investigational devices.

The Clinical Research Operations Associate will report to Harry G. Mitchell, COO. For additional information about the position, contact Harry G. Mitchell: hgm7s@virginia.edu. This position is located in Charlottesville, VA. This position is a restricted position and is dependent upon project need, availability of funding, and performance. Anticipated hiring range is commensurate with education and experience. This is an exempt-level, benefited position. For more information on the benefits at UVA, visit hr.virginia.edu/benefits. This position will not sponsor applicants for work visas.

The University will perform background checks on all new hires prior to employment. A completed pre-employment health screen and drug screen are required for this position prior to employment.

For more information about UVA and the Charlottesville community, please see http://www.virginia.edu/life/charlottesville and https://embarkcva.com/.


 


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Please visit the UVA COVID-19 Job Requirements and Guidelines webpage prior to applying for current information regarding vaccination requirements and guidelines for employment at UVA.

 

 

 


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