Clinical Research Operations Associate, PA/NP, Center of Diabetes Technology (UVA)

University of Virginia; Charlottesville (VA); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Clinical Research Operations Associate to support innovative diabetes research. In this pivotal role, you will assist physicians and clinical teams in executing research studies, ensuring compliance with protocols, and managing participant interactions. Your expertise will contribute to groundbreaking studies that aim to improve diabetes care. This position offers a unique opportunity to work alongside renowned researchers in a dynamic environment, where your contributions will directly impact the future of diabetes technology. If you are passionate about clinical research and eager to make a difference, this role is for you.

Qualifications

• Graduate of an accredited program with a Master's degree required.
• 1-year clinical experience in area of expertise needed.

Responsibilities

• Assist with clinical research studies and document findings.
• Communicate with sponsors and maintain compliance with protocols.

Skills

Clinical Research

Communication Skills

Medical Management

Adverse Events Assessment

GCP/ICH Guidelines Knowledge

Education

Master's Degree in Nursing or Physician Assistant Program

Tools

Desktop Computers

Job description

Clinical Research Operations Associate, PA/NP, Center of Diabetes Technology (UVA)

Pay Competitive

Employment type: Full-Time

Job Description

• Req#: R0040042

The UVA Center for Diabetes Technology seeks a Clinical Research Operations Associate, PA/NP. The Clinical Research Operations Associate is responsible for support 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, 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, comprised 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 inter-professional research team members to facilitate clinical research studies.
• Exercise professional judgement 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, identifies issues for discussion with physicians and with other research staff, documents and clearly communicates 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/post graduate 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 clinical experience in area of expertise.

Licensure: License or license eligible as an Advance Practice Provider (Nurse Practitioner, Physician Associate, 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:

• Experienced in the treatment and management of T1 and T2 Diabetes Mellitus including therapeutics, insulin pump therapy, and continuous glucose monitors.
• Experienced 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; [e-mail]. 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.

To Apply:
Process for Internal UVA Applicants: Please apply through your Workday Home page, search “Find Jobs”, and search for “R0040042”.

Process for External Applicants: Please visit UVA job board at https://uva.wd1.myworkdayjobs.com/UVAJobs and search for “R0040042”.

Complete an application online with the following documents:

• CV/Resume
• Cover letter

Upload all materials into the resume submission field, multiple documents can be submitted into this one field. Alternatively, merge all documents into one PDF for submission. Applications that do not contain all required documents will not receive full consideration.

References will be completed via UVA’s standardized process Skill Survey. A total of five references will be requested via SkillSurvey during the final phase of the interview process.

For questions about the application process, please contact Christi Maguire, Recruiting Specialist, at [e-mail]. For more information about UVA and the Charlottesville community please see http://www.virginia.edu/life/charlottesville and https://embarkcva.com/.

The University of Virginia, including the UVA Health System which represents the UVA Medical Center, Schools of Medicine and Nursing, UVA Physician’s Group, and the Claude Moore Health Sciences Library, are fundamentally committed to the diversity of our faculty and staff. We believe diversity is excellence expressing itself through every person's perspectives and lived experiences. We are equal opportunity and affirmative action employers. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender identity or expression, marital status, national or ethnic origin, political affiliation, race, religion, sex (including pregnancy), sexual orientation, veteran status, and family medical or genetic information.

About the company

The University of Virginia is a public research university in Charlottesville, Virginia, founded in 1819 by Thomas Jefferson.