Non-licensed Clinical Research Coordinator; varying levels), Gastroenterology and Hepatology

Overview

The Division of Gastroenterology and Hepatology at the University of Virginia’s School of Medicine is seeking applicants for non-licensed Clinical Research Coordinators (CRC) at various skill and experience levels to join a dynamic and growing team of clinical research professionals. This position is open to applicants who meet the requirements of Clinical Research Coordinator 2-3.

This position will work closely with world-renowned Principal Investigators and other Research Team members during the performance of clinical trials. The incumbent is responsible for maintaining quality management of the trial portfolio and collaborates with other CRCs on the Research Team.

• Independently coordinate and manage multiple clinical research studies and drug/device trials across academic and health system settings.
• Interface with study sponsors and monitors to coordinate and oversee all aspects of clinical research projects, including study start-up, site initiation, study maintenance, monitoring, and close-out visits.
• Oversee site visits, address sponsor queries, and ensure adherence to study protocols and regulatory requirements throughout all study activities.
• Act as a liaison between patients and physicians, coordinate patient care in compliance with protocol requirements. Dispense investigational drug and provide patient teaching regarding administration.
• Manage logistical and administrative aspects of clinical research projects by maintaining inventory of supplies and equipment, preparing lab kits and requisitions, organizing and maintaining study documents including regulatory binders and source documents, and tracking deliverables. Review protocol-specific billing guides and submit billing information; reconcile study billing and identify charges covered by the study versus charges billed to the subject/third party payor.
• Present trial concepts and details to patients, manage participant engagement throughout clinical research studies by identifying and recruiting eligible subjects, conducting informed consent/assent processes, coordinating subject reimbursement, verifying participant eligibility, and serving as the primary point of contact for study-related inquiries and support.
• Perform clinical skills including taking vital signs, electrocardiograms and other protocol-related procedures that may require additional training.
• Support the PI and other study staff in following study participants through all study activities to ensure that the study is conducted in compliance with Good Clinical Practice (GCP) requirements; provide timely and accurate exchange of participant information with the PI and research team as it pertains to study conduct and patient safety; collaborate with the study team to organize and prioritize workload to meet deadlines.
• Proficient user of the electronic platforms used in clinical research (IRB Pro, Protocol Builder, CRConnect, OnCore, e-regulatory platforms, and Epic).
• 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.
• Ability to train, guide, and mentor peers.

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. Licensure:
None.

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 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) is preferred at the time of hire and is required within one year.

• Exceptional organizational skills with ability to manage multiple simultaneous studies.
• Strong verbal and written…