Clinical Research Coordinator , Non-licensed; Asthma, Allergy and Immunology

The Division of Asthma, Allergy and Immunology is seeking a full time Clinical Research Coordinator 3, Non-Licensed (CRC-3, NL) to perform a full range of clinical research duties with minimal supervision. The candidate must have an advanced level of knowledge of clinical research conduct, good clinical practices as well as federal and state regulations that govern it. The candidate must be able to perform progressively more complex and comprehensive clinical research duties with an increasing level of autonomy and will work closely with Principal Investigators and other members of the research team.

In this role the CRC-3, NL may manage or support a research team of CRCs.

• Work closely with Principal Investigators and other study team members on all clinical research projects assigned.
• Able to work with minimal supervision.
• Demonstrate a working knowledge of the regulatory framework for FDA and non-FDA regulated studies.
• Facilitate and / or complete activities required for study start-up including: contract and budget negotiations, regulatory submissions and all communications with the study Sponsor.
• 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.
• Prepare and submit all regulatory documentation to the IRB such as: personnel changes, annual protocol continuations, protocol modifications, adverse event reports, unanticipated events.
• Reconcile study billing, identify charges covered by the study, versus charges to be billed to the subject/third party payor.
• Orient and/or provide basic training to new study team members.
• May manage or lead a team of Clinical Research Coordinators and/or laboratory or research support staff, with responsibilities that include hiring, scheduling, workload, compensation, rewards, professional development, and performance management.
• Ensure Sponsor is invoiced for study activity and reconcile payments received.
• Notify PI and / or supervisor of any potential issues with the study or subject status.
• Communicate effectively with study Sponsor(s).
• Liaise with the other Departments within the institution to support clinical research activities.
• Demonstrate a high level of proficiency with the various electronic platforms utilized in clinical research such as: IRB Pro, Protocol Builder, CRConnect, OnCore, e-regulatory platforms and Epic.
• Support investigator-initiated research activity by conducting literature searches, collating research material, assisting with abstract or manuscript preparation.
• 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.

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.

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

• Research coordination experience in the specialties of allergy, asthma, immunology and/or pulmonology.
• Research coordination experience in asthma and other chronic lung disease industry sponsored clinical trials.
• Direct experience as a CRC in clinical trials in the Department of Medicine at the University of Virginia.
• Extensive firsthand knowledge of University of Virginia institutional systems, processes and requirements.
• Successful track record of meeting recruitment goals for clinical trials.
• Experience leading, mentoring and supervising clinical research staff.

This is primarily a sedentary job involving extensive use of desktop computers. The job does occasionally require traveling some distance…