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Clinical Research Coordinator 1 or 2, Licensed or Non-Licensed, Department of Pediatrics

University of Virginia
Clinical Department Wingfull_timeVerifiedPosted 18 Dec 2023

About the role

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 experience levels CRC 1 and CRC 2. The CRC will support clinical research efforts for the Pediatrics Department throughout several divisions as needed. The individual will be responsible for assisting the PIs and other faculty in conducting National Institute of Health (NIH), industry sponsored clinical trials, and/or investigator-initiated trials. In this role, the CRC will work closely with the clinical team including faculty, advanced practice providers, and staff. The focus of clinical research activities will vary based on the clinical trial portfolio and include patient facing activities, compliance management and clinical research administrative responsibilities.

There is a heavy focus on education to provide a strong foundational level of knowledge in clinical research as a whole. This is a role that involves intense cumulative learning to lay the groundwork for a successful career as a clinical research coordinator. A CRC 1 and CRC 2 will work under direct supervision of a Principal Investigator and/or an experienced CRC and will be assigned clinical research duties as deemed appropriate by a designated supervisor.

The successful candidate will be expected to:

  • Work closely with an experienced CRC and/or Principal Investigator to learn the full scope of clinical research duties.
  • With the mentorship of a CRC and/or PI, learn how to read and follow a clinical trial protocol as it is written.
  • Demonstrate a clear understanding of the importance of patient safety in clinical research and identify the components of a clinical trial protocol that are employed to protect patient safety.
  • Engage in the following study conduct activities: screen and identify eligible patients, obtain and document informed consent, enroll subjects in a study.
  • Manage ongoing study conduct activities such as: coordinate study visits, maintain concomitant medication records, track and report adverse events, organize subject study payments.
  • Collect and enter study data in a timely fashion, maintain corresponding documentation.
  • Collect, process, store and ship study specimens as needed.
  • Assist in preparation and maintenance of existing study documentation such as: study visit schedules, study drug diaries, monitoring and or training logs, equipment records or study communications.
  • Prepare and submit basic regulatory documentation to the IRB such as: personnel changes, annual protocol continuations, and minor protocol modifications.
  • Become familiar 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.
  • In addition to the above job responsibilities, other duties may be assigned.
  • To be promoted, a CRC 1 must demonstrate a basic understanding of clinical research processes and regulations (federal and local) that govern the conduct of clinical research.

Qualified candidates MUST have:

Education: Bachelor's Degree Required or equivalent combination of experience, education and or certifications.
Experience: None. Some experience in a healthcare setting and/or knowledge of medical terminology is preferred.
 

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 position is located in Charlottesville, VA.  

 

This position will remain open until filled. This 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 and drug screen is also required for this position prior to employment.   

 

TO APPLY 

Please apply through UVA Careers Page, and search for R0055828. Internal applicants must apply through their UVA Workday profile by searching 'Find Jobs'. Complete an application online with the following documents: 

  • CV or 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.  

 

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Company

University of Virginia

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