Clinical Research Coordinator 1-2; Pediatrics

UVA Health • Charlottesville, VA

4d • $60,000 - $70,000 • Onsite

About The Position

The Department of Pediatrics at the University of Virginia (UVA) School of Medicine is seeking candidates for a Clinical Research Coordinator (CRC), non-licensed, at experience levels CRC 1 and CRC 2. The CRC will support clinical research efforts for the Pediatrics Department Chair and other divisions within the Department. This role involves assisting faculty in conducting NIH, industry-sponsored, and investigator-initiated clinical trials. The CRC will collaborate closely with the clinical team, including faculty, advanced practice providers, and staff. The focus of clinical research activities will vary based on the trial portfolio and will include patient-facing tasks, compliance management, and administrative responsibilities. Clinical Research Coordinators at levels 2 and above are expected to understand the clinical research process and regulations (federal and local) and be able to manage multiple complex clinical trials simultaneously while maintaining audit-ready study documentation.

Requirements

• Bachelor's Degree Required or equivalent combination of experience, education and or certifications.
• None (for CRC1).
• At least one year of clinical research experience (for CRC2).
• Some experience in a healthcare setting and/or knowledge of medical terminology is preferred.
• Background checks, pre-employment health screenings, and drug screenings will be conducted on all new hires prior to employment.

Nice To Haves

• Some experience in a healthcare setting and/or knowledge of medical terminology is preferred.

Responsibilities

• Work closely with Principal Investigators and other study team members on all clinical research projects assigned.
• Become familiar with study start-up processes and requirements for: non-disclosure agreements, data use and material transfer agreements, clinical trial agreements, development of clinical trial budgets.
• Assist in preparation, maintenance or creation of study documents such as: study visit schedules, study drug diaries, monitoring or training logs, equipment records or study communications.
• Manage study recruitment and enrollment efforts including: screen and identify eligible patients, obtain and document informed consent and enrollment.
• Manage ongoing study conduct activities such as: schedule and coordinate study visits, maintain concomitant medication records, track and report adverse events, organize subject study payments.
• 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.
• Collect process, prepare, store and ship laboratory specimens as necessary.
• Prepare and submit necessary documents for Institutional Review Boards (IRB), FDA, National Institutes of Health (NIH) or Data Safety Monitoring Board (DSMB) review; document and report protocol deviations.
• 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, identify 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.

Benefits

• Learn more about UVA benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level