Clinical Research Coordinator 2-4; Pediatrics

University of Virginia

7d•Onsite

About The Position

The Department of Pediatrics in the University of Virginia’s (UVA) School of Medicine is seeking candidates for a Clinical Research Coordinator (CRC), licensed or non-licensed, at experience levels CRC 2 through CRC 4. 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: https://med.virginia.edu/pediatrics/.

Requirements

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.
Licensure: None.
CRC3 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.
CRC4 non-licensed
Education: Bachelor's Degree Required or equivalent combination of experience, education and or certifications.
Experience: At least seven years of clinical research experience demonstrating progressive levels of responsibility and complexity of work. Master’s or other advanced degree may substitute for one year of clinical research experience.
Licensure: Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is required within one year of hire.

Nice To Haves

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

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.