Clinical Research Coordinator - Department of Pediatrics, Division of Neonatology

State of Virginia•Charlottesville, VA

40d•Onsite

About The Position

The Department of Pediatrics at the University of Virginia (UVA) School of Medicine is seeking a full-time Clinical Research Coordinator (CRC), Level 2 or 3, to support clinical research efforts working with Dr. Julia Johnson. This position will support Dr. Johnson's research program, clinical trials, as well as investigator-initiated studies, including projects related to neonatal global health, infection epidemiology, and prevention. The CRC will work closely with faculty, nursing, and research staff, and will coordinate with both U.S.-based and international collaborators. While international travel is not required, it may be an option depending on interest and travel restrictions.

Requirements

Clinical Research Coordinator 2, Non-Licensed
Education: Bachelor's Degree Required or equivalent combination of experience, education and or certifications.
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 3, Non -Licensed
Education: Bachelor's Degree Required or equivalent combination of experience, education and or certifications.
Experience: Minimum of 3 years of clinical research experience. Master's degree may substitute for 1 year of clinical research experience.

Nice To Haves

Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is preferred at the time of hire and is required within one year.

Responsibilities

Coordinate the implementation of study protocols in collaboration with Principal Investigators (PIs) and co-investigators.
Maintain working knowledge of all assigned protocols and ensure adherence to regulatory and reporting requirements.
Collect and manage clinical research data using platforms such as REDCap, Excel, Epic, OnCore, and others.
Abstract clinical data from electronic medical records and maintain audit-ready documentation.
Prepare and submit IRB documents including initial submissions, amendments, renewals, and adverse event reports.
Communicate effectively with study sponsors, collaborators, and internal/external stakeholders, including scheduling of meetings and follow up on study progress.
Process, prepare, and ship laboratory specimens as required by study protocols.
Support and assist in manuscript preparation and grant proposal development, including drafting and editing research strategy sections under guidance of PI, preparing tables, charts, figures, writing, editing and assembly.
Manage study billing reconciliation and distinguish between study-covered and third-party charges.
Train and orient new study team members and contribute to mentorship and knowledge-sharing.
Participate in regular team meetings to review study progress and data quality.
Demonstrate increasing proficiency with clinical research platforms (e.g., IRB Pro, Protocol Builder, iMedidata, Inform, OpenClinica).
Ensure compliance with federal, state, and institutional regulations for both FDA and non-FDA regulated studies.