Clinical Research Coordinator 1-2; Pediatrics

The Department of Pediatrics in the University of Virginia's (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 as well as other divisions across the Department as needed. The individual will be responsible for assisting the Pediatrics Department Chair 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. Clinical Research Coordinators levels 2 through 4 will have an understanding of the clinical research process and regulations, both federal and local, governing the conduct of clinical research. They will be able to manage multiple complex clinical trials simultaneously in accordance with current regulatory requirements and maintain study documentation in a manner that is audit-ready

For more information on the mission of the UVA Department of Pediatrics and the UVA Children's Hospital, please visit:

Responsibilities of the successful candidate will vary based on the CRC level at the time of hire but include:

• 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.

MINIMUM REQUIREMENTS

CRC1 non-licensed

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.

The anticipated hiring range is $25-27/hour; commensurate with education and experience

CRC2 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.

The anticipated hiring range is $60,000-70,000 annual, commensurate with education and experience.

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.

Salary will be commensurate with education, experience, and job level. Learn more about UVA benefits.

This is a restricted position, which is dependent on funding and is contingent upon funding availability. This position is based in Charlottesville, VA, and must be performed fully on-site.

About UVA and the Community

To learn more about UVA and in the Charlottesville area, visit UVA Life and Embark CVA.

Additional Requirements

Background checks, pre-employment health screenings, and drug screening s will be conducted on all new hires prior to employment.

How to Apply

Please apply online, by searching for requisition number R0084111. Complete an application with the following documents:

• Resume
• Cover Letter

Upload all materials into the resume submission field. You can submit multiple documents into this one field or combine them into one PDF. Applications without all required documents will not receive full consideration.

Internal applicants: Search and apply for jobs on the UVA Internal Careers website.

Reference Check Process

Reference checks will be completed by UVA's third-party partner, SkillSurvey, during the final phase of the interview. Five references will be requested, with at least three responses required.

Contact

For questions about the application process, please contact Jeremy Brofft, Senior Academic Recruiter at View email address on click.appcast.io.

The University of Virginia is an equal opportunity employer. All interested persons are encouraged to apply, including veterans and individuals with disabilities. Learn more about UVA's commitment to non-discrimination and equal opportunity employment .