Clinical Research Coordinator 3 or 4, Department of Pediatrics UVA Intensive Care (NICU, PICU)
Job ID: R0043944 | Clinical Research | Full Time | Charlottesville, VA
The Department of Pediatrics at the University of Virginia (UVA) School of Medicine seeks a candidate for a Clinical Research Coordinator 3 or 4, non-licensed or licensed, to assist with oversight of intensive care clinical trials. The successful applicant will work primarily on clinical trials conducted in the neonatal intensive care unit (NICU) and will assist investigators in pediatric intensive care unit (PICU) to support and expand the current PICU clinical research program. A Clinical Research Coordinator 3 or 4 will be expected to plan, organize, lead, and perform comprehensive and advanced-level clinical research duties for multiple and/or complex clinical trials. Our preferred candidate for this position will have the ability to directly impact the overall efficiency, productivity, and success of each clinical trial they coordinate. The CRC in this role will be able to work independently and has the authority to interact with internal or external stakeholders involved in a clinical trial or modify clinical trial workflow or processes within their respective department or division to meet the needs of a given study in collaboration with the manager of the team. As a key member of the research team, you will work closely with the Clinical Research Operations Manager and physicians in both the NICU and the PICU. This position requires the ability to work rotating weekends and on-call shifts, alternating with others within the department as needed for study requirements. The successful candidate will be required to manage multiple complex clinical trials simultaneously in accordance with current regulatory requirements and maintain all study documentation in a manner that is "audit-ready."

The successful candidate will be expected to:
  • Screen electronic medical records (EMR) for potential study candidates and track screening efforts.
  • Recruit and obtain informed consent from study participants and maintain telephone and in-person contact.
  • Manage ongoing study conduct activities, such as coordinating study treatment, maintaining concomitant medication records, tracking and reporting adverse events, and organizing subject study payments.
  • Work closely with principal investigators (PI) and other study team members on clinical research projects assigned.
  • Demonstrate a working knowledge of the regulatory framework for FDA and non-FDA regulated studies.
  • Work well with minimal supervision.
  • Facilitate and/or complete activities required for study start-up, including regulatory submissions and all communications with the study sponsor.
  • Coordinate multiple clinical trials or research projects simultaneously or manage large individual clinical trials that may be multicenter and complex in nature.
  • Manage all aspects of ongoing clinical trial conduct from enrollment to off-study visits, data management, safety reporting, and compliance oversight.
  • Prepare and submit all regulatory documentation to the IRB, such as personnel changes, annual protocol continuations, protocol modifications, adverse event reports, and unanticipated events.
  • Support investigator-initiated research activity, including study feasibility assessment, clinical trial protocol development, compliance oversight, and study conduct.
  • Reconcile study billing; identify study charges versus payments to the subject or third-party vendor.
  • Orient, train, and mentor new study team members.
  • Ensure sponsor is invoiced for study activity and reconcile payments received.
  • Notify PI and/or Clinical Research Operations Manager of potential issues with the study or subject status.
  • Communicate effectively with study sponsor(s).
  • Liaise with the other departments within the institution to support clinical research activities.
  • Demonstrate a high level of proficiency with 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.
  • Process, prepare, and ship study research samples
  • Ability to work a flexible schedule, when needed, given the nature of the studies open to enrollment.
  • Ability to work on weekends, when needed, given the nature of the studies open to enrollment.
  • Support and provide guidance to faculty and trainees with clinical research projects in the department.
  • In addition to the above job responsibilities, other duties may be assigned.

Qualified candidates must have:

Clinical Research Coordinator 3, Non-Licensed
  • Education: Bachelor's degree required or equivalent combination of experience, education, and/or certifications.
  • Experience: Minimum of three years of clinical research experience required. Master's degree may substitute for one year of clinical research experience.
  • Licensure: Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is preferred at the time of hire and is required within one year.

Clinical Research Coordinator 3, 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 three years of clinical research experience required. Master's or advanced degree may substitute for 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.

Clinical Research Coordinator 4, Non-Licensed
  • Education: Bachelor's degree required. Master's or other advanced degree preferred.
  • 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 preferred at the time of hire and is required within one year.

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. 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 Experience:
  • Experience with Epic EMR, collection, and processing of blood draws for research.
  • Experience with OnCore, Advarra, and WCG IRB.
  • Experience managing several open clinical trials at the same time.

Required Knowledge, Skills and Abilities:
  • Excellent interpersonal and communication skills.
  • Ability to work independently and as part of a team.
  • Ability to prioritize competing tasks and take initiative.
  • Ability to plan and execute project and keep the study team up to date.
  • Effective use of Microsoft Office (Word, Excel, PowerPoint, and Outlook) is required.
  • Experience with Epic EMR, collection of biomarkers such as blood draws, and experience in a clinical environment.
  • Strong analytical 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.

The Clinical Research Coordinator 3 or 4 will report to the Clinical Research Operations Manager. For additional information about the position, please contact Monika Thielen, ART, BComm, CCRP at mjt3c@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. This is an exempt-level, full-time, benefited position. For more information on the benefits at UVA, visit www.hr.virginia.edu/benefits.

The position will remain open until filled. This position will not sponsor applicants for work visas. The anticipated hiring range is commensurate with education and experience.

The University will perform background checks on all new hires prior to employment. A completed pre-employment health screen and drug screening 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/.

The University of Virginia School of Medicine and affiliated UVA Health form the premier medical and research institution in the Commonwealth of Virginia and have a rich tradition of discovery, translational, clinical, and health services/outcomes-based research grounded in a culture of collaboration and service. Three Nobel laureates have called UVA their home. The University is located in Charlottesville, VA, situated in the Blue Ridge Mountains and picturesque Shenandoah Valley, just 100 miles from Washington, D.C. Our region boasts outstanding opportunities for outdoor recreation year-round, including hiking, water-based activities, and skiing. Virginia Beach and other types of coastal recreation are also accessible. For more information about the Department of Pediatrics, please see https://med.virginia.edu/pediatrics/.

Employee benefits package highlights include:
  • 22 days of paid time off, increasing with service; 13+ paid holidays each year, in addition to paid time off; parental and community service leave
  • Health plan with options to meet healthcare and financial needs
  • Retirement through the Virginia Retirement System
  • Tuition and professional development benefits
  • Employee wellness program featuring activities to earn up to $500/year



COVID Vaccination Requirement and Guidelines

 

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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