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The University of Virginia's Center for Diabetes Technology is seeking a Nurse (RN or LPN) Licensed Clinical Research Coordinator, (Levels 2, 3 or 4). The Center for Diabetes Technology is a world leader in the technological treatment of diabetes and is aimed at improving the management, monitoring, and therapies for persons with Type 1 and Type 2 Diabetes. This position will coordinate and implement clinical trial research studies mainly focused on industry sponsored clinical trials, working closely with the Principal Investigators, Operational Managers, and other research team members during the performance of the trials. The Clinical Research Coordinator/Nurse, under the guidance and supervision of the Principal Investigator (PI), ensures the integrity and quality of clinical trials are maintained and conducted in accordance with Food and Drug Administration (FDA), state, and local regulations, Institutional Review Board (IRB) approvals, Office for Human Research Protection (OHRP) policies and procedures and Good Clinical Practice (GCP) Guidelines. This position is primarily responsible for coordination with the trial Sponsor, the accurate completion of visit procedures and, execution of the trial including the collection of information from clinical study patients according to protocols, and for protecting the health, safety, and welfare of clinical research participants. Job Responsibilities Include:
Attending the necessary meetings related to the research including but not limited to site initiation visit, protocol training and scheduled meetings with PIs and /or sponsors. Participating in recruitment and selection of study participants by interviewing and documenting medical history to determine compliance with eligibility requirements Collecting basic information through scripted and non-scripted interviews. Planning and executing tasks related to the study protocol. Organizing and planning tasks related to the study protocol. Obtaining informed consent from study participants and maintaining telephone and in-person contact. Collecting subject data, maintaining appropriate logs, tracking participants, and preparing study materials. Processing, preparing and shipping laboratory specimens. Ensuring site compliance with research protocols by reviewing all regulatory requirements to confirm implementation of appropriate methods, practices, and procedures for all research activities Ensuring compliance with research protocols, by providing ongoing quality control audits, including maintaining ongoing investigational drug accountability Performing medical tests, including, but not limited to, vital signs, imaging studies, electrocardiograms, blood draws, IV placement Administering investigational medications and performing patient assessments during clinic visits to determine presence of side effects; notifying Principal Investigator of findings/issues Providing patient education and medical information to study patients to ensure understanding of proper medication dosage, administration, and disease treatment Developing accurate source materials and ensures compliance from site staff Providing accurate and timely data collection, documentation, entry, and reporting in both UVA and Sponsors database Supporting the regulatory staff in the maintenance of regulatory documents in accordance with UVA-IRB, FDA, Central-IRB SOP and applicable regulations Communicating and collaborating specific study requirements to the research team, including internal and external parties, sponsor, monitors, PI, and study participants
Qualifications and Requirements:
Valid Nursing License from the State of Virginia Baccalaureate or equivalent diploma status Knowledge of medical terminology, drug calculation skills, clinical medicine, clinical trials and GCP concepts Detail oriented and meticulous in all aspects of work Strong follow through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative Must have professional demeanor, strong communication skills with the public as well as physicians and co-workers Ability to work independently as well as in team environment Strong interpersonal, customer service and multi-tasking skills are critical Must be proficient in Microsoft Office Word and Excel, electronic health systems and databases used in research environment, or have a willingness to learn and demonstrate proficiency within six months of hire Possess the ability to work well under pressure, multi-task, and manage deadlines Knowledge of Good Clinical Practice (GCP), federal, state, and local regulations, including HIPAA policies and procedures
MINIMUM REQUIREMENTS: 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 (RN), Nurse practitioner (NP), Bachelor of Science in Nursing Degree (BSN), Doctor of Nursing Practice (DNP) or PhD in Nursing Clinical Research Coordinator, 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: A minimum of 3 years of clinical research experience required. Master's or advanced degree may substitute for 1 year of clinical research experience.
Licensure: Licensed to Practice in Clinical Profession such as (but not limited to): Registered Nurse (RN), Nurse practitioner (NP), Bachelor of Science in Nursing Degree (BSN), Doctor of Nursing Practice (DNP) or PhD in Nursing Clinical Research Coordinator 4, 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 seven years of clinical research experience demonstrating progressive levels of responsibility and complexity of work. Master's or other advanced degree may substitute for one year of clinical research experience.
Licensure: Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is required within one year of hire. Licensed to Practice in Clinical Profession such as (but not limited to): Registered Nurse (RN), Nurse practitioner (NP), Bachelor of Science in Nursing Degree (BSN), Doctor of Nursing Practice (DNP) or PhD in Nursing Preferred Experience:
Regulatory experience is a plus. Experience with managing multiple clinical research studies simultaneously Proficiency in computer/automated systems for data entry and reporting purposes Effective use of Microsoft Office (Word, Excel, PowerPoint, and Outlook) and Microsoft OneDrive
Physical Requirements:
Moderately walking to attend the clinical trial participants at the Clinical Research Unit or a place where the trial is conducted such as outpatient facility Occasionally lift of material/boxes when clinical trial and supplies are delivered up to 35 pounds
This position is located in Charlottesville, Virginia. This is an exempt level, benefited position. For more information on the benefits at UVA, visit hr.virginia.edu/benefits. This position is a restricted position and is dependent upon project need, availability of funding and performance. The University will perform background checks on all new hires prior to employment. A completed pre-employment health screen is required for this position prior to employment. To Apply: Please apply through the UVA job board, and search for R0065629. Internal applicants must apply through their UVA Workday profile by searching 'Find Jobs' and search for R0065629. Complete an application online with the following documents:
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 Skill Survey during the final phase of the interview process. For questions about the application process, please contact Michelle Johnson, Recruiter. 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, pregnancy, sexual orientation, veteran or military status, and family medical or genetic information.
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The Rector & Visitors of the University of Virginia
Nov 11, 2024