Clinical Research Coordinator, Varying Levels - Department of Pediatrics
Job ID: R0039815 | Clinical Research | Full Time | Charlottesville, VA
The Department of Pediatrics in the University of Virginia's (UVA) School of Medicine is seeking candidates for a Clinical Research Coordinator (CRC), licensed or non-licensed, at all experience levels, including CRC 1 through CRC 4. The CRC will support clinical research efforts in divisions across the department as needed. The individual will be responsible for assisting principal investigators in conducting National Institute of Health (NIH), industry-sponsored clinical trials or investigator-initiated trials. In this role, the CRC will work closely with the clinical teams, including faculty, nursing, and staff. The focus of clinical research activities will vary based on the portfolio of clinical trials and include patient-facing activities, compliance management, and clinical research administrative responsibilities.

Clinical Research Coordinators, level 1 learn and assist with a variety of clinical research activities. Clinical Research Trainees perform work at the task level under close supervision. To be promoted, trainees must demonstrate a basic understanding of the clinical research process and the regulations, both federal and local, governing the conduct of clinical research. Clinical Research Coordinators, level 2 through 4 manage multiple complex clinical trials simultaneously in accordance with current regulatory requirements and maintain study documentation in a manner that is audit-ready.

For more information on the mission of the UVA Department of Pediatrics and the UVA Children's Hospital, please visit https://med.virginia.edu/pediatrics/

Responsibilities of the successful candidate will vary based on the CRC level at the time of hire but include:
  • Work closely with principal investigators and other study team members on all clinical research projects assigned.
  • Notify PI and/or supervisor of any potential issues with the study or subject status.
  • Communicate effectively with study sponsor(s).
  • Liaise with other groups outside of the Department of Pediatrics to support clinical research activities that will enable us to run trials in an effective manner.
  • Collect subject data, maintain appropriate logs, track participants, and prepare study materials.
  • Perform data entry into internal and external electronic databases.
  • Process, prepare, and ship laboratory specimens.
  • Prepare documents for Institutional Review Boards (IRB) submissions.
  • Able to work with minimal supervision.
  • Demonstrate a working knowledge of the regulatory framework for FDA and non-FDA regulated studies.
  • 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.
  • Reconcile study billing, identifying charges covered by the study versus charges to be billed to the subject/third-party payer.
  • Orient and/or provide basic training to new study team members.
  • Demonstrate a high level of proficiency with the various electronic platforms utilized in clinical research, such as IRB Pro, Protocol Builder, OnCore, iMedidata, Inform, Openclinica, Epic, and other data management platforms.
  • 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.

Qualified Candidates Must Have:

Clinical Research Coordinator 1, Non-Licensed:
  • Education: Associate's degree required; bachelor's degree preferred. Four years of clinical research experience can be considered in lieu of a degree.
  • Experience: None. Some experience in a healthcare setting and/or knowledge of medical terminology is preferred.

Clinical Research Coordinator 1, Licensed:
  • Education: Associate's degree required; bachelor's degree preferred. Nursing diploma may substitute for an associate's degree for licensed Registered Nurse.
  • Experience: None. Some experience in a healthcare setting and/or knowledge of medical terminology is preferred.
  • Licensure: Licensed to practice in a clinical profession such as (but not limited to): Registered Nurse, Athletic Training, Pharmacology, Medical Technology, Physical Therapy, or Registered Respiratory Therapy.

Clinical Research Coordinator 2, Non-Licensed:
  • Education: Associate's degree required; bachelor's degree preferred. Four years of clinical research experience can be considered in lieu of a degree.
  • Experience: At least one year of clinical research experience. Some experience in a healthcare setting and/or knowledge of medical terminology is preferred.

Clinical Research Coordinator 2, Licensed:
  • Education: Associate's degree required; bachelor's degree preferred. Nursing diploma may substitute for an associate's degree for licensed Registered Nurse.
  • Experience: At least one year of clinical research experience.
  • Licensure: Licensed to practice in a clinical profession such as (but not limited to): Registered Nurse, Athletic Training, Pharmacology, Medical Technology, Physical Therapy, or Registered Respiratory Therapy.

Clinical Research Coordinator 3, Non-Licensed:
  • Education: Associate's degree required; bachelor's or master's degree preferred. Five or more years of clinical research experience may be considered in lieu of a degree.
  • Experience: Minimum of 3 years of clinical research experience required. Master's degree may substitute for 1 year of clinical research experience.
  • Licensure: Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) are preferred at the time of hire and are required within one year.

Clinical Research Coordinator 3, Licensed:
  • Education: Associate's degree required; bachelor's or master's degree preferred. Nursing diploma may substitute for an associate's 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, 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.

Clinical Research Coordinator 4, Licensed:
  • Education: Associate's degree required; bachelor's or master's degree preferred. Nursing diploma may substitute for an associate's 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) are 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.

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 will report to the Department of Pediatrics Clinical Research Operations Manager.

For additional information about the position, please contact Monika Thielen at mjt3c@virginia.edu

This is a restricted position; continuation is dependent on funding and satisfactory performance. The position will remain open until filled. This position is located in Charlottesville, Virginia.

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.

This is a full-time benefited position. For more information on the benefits at UVA, visit www.hr.virginia.edu/benefits.

This position will not sponsor applicants for work visas.

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



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.

 

 

 


Charlottesville, VA
Charlottesville, VA 22903

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