CTU Service Spotlight – CRC Pool

On May 20, 2024 — 2024 National Clinical Trials Day — UVA School of Medicine inaugurated the launch of a new, full-service, Clinical Trials Unit (CTU) to help UVA School of Medicine, UVA Health, and UVA achieve our shared mission of research excellence. The CTU is intended to be a multi-tier resource for the entire UVA research community in achieving the “enabling discoveries for better health” goal of UVA Health’s strategic plan. In each edition of CTU Currents we will explore one of the services offered by the CTU and we are kicking things off with a look at the Clinical Research Coordinator (CRC) Pool.

The National Institutes of Health defines a CRC as someone who “manages and conducts the day-to-day activities of a clinical trial. The Principal Investigator (PI) determines the CRC’s specific responsibilities and works closely with the CRC. In general, the CRC ensures the clinical study maintains accordance with the protocol, applicable regulations, and Good Clinical Practice (GCP) and Institutional Review Board (IRB) requirements. Beyond administrative duties, responsibilities of a CRC may include acting as a liaison for the clinical site, ensuring staff are properly trained per the protocol, recruiting and/or registering participants, maintaining study guidelines, and collecting and/or reviewing the data or review before it is entered into a study database.”

“As integral as CRCs are to the conduct of clinical research, it can sometimes be difficult to hire, train, and retain CRCs”, according to Susan Hamil, RN, the CRC Pool Program Manager.  Additionally, some smaller scale projects may not have the funding or the need for a full-time CRC. Yet finding a qualified candidate who is willing to work part-time can be a challenge. This administrative burden can cause delays for principal investigators eager to start their research projects. According to Hamil, “Study teams that can hit the ground running with proficient CRCs experience quicker study start-up and implementation timelines along with smoother protocol visits, cleaner data, and less regulatory findings. The CRC Pool is positioned to supercharge research projects at UVA by delivering proficient CRCs precisely when and where they are needed most.”

The SOM CTU is committed to providing any UVA investigator with trained CRCs who are ready to assist with various tasks including:

• temporary coverage for CRCs out on leave
• supplement existing CRC staff during times of accelerated timelines/enrollment
• continuity during study team turnover
• CRC support for PIs who do not have funding for a full time CRC

Training and Services:

All SOM CTU CRCs are CITI trained in human subject research protections and Good Clinical Practice (GCP) and have completed training for shipping infectious substances and dry ice (IATA certification). Additionally, these CRCs are proficient with EPIC, Oncore, Florence, REDCap, and multiple EDC systems.  Our CRCs have diverse experience working with multiple sponsors and systems across many UVA departments.

Examples of CRC services that our team can provide:

• Project management oversight from study start up to study closure
• Consenting subjects (in-person and virtual)
• Eligibility review and subject enrollment
• Conduct protocol visits in compliance with protocol
• Process and ship laboratory samples to central laboratories
• Upload imaging to central imaging vendors
• Data entry/query resolution
• Facilitate monitoring visits and prepare for audits
• Build CRFs in REDCap
• Study archival

Payment and Fees:

SOM CTU CRCs are available as a fee for service program. This service can be used by any UVA investigator who needs CRC support.

• CRC support is charged at an hourly rate
• All project specific time is tracked in Oncore and the PI will be invoiced monthly through iLAB
• For new projects still in study start-up, the CRC Program Manager can give an estimate of CRC hours for budget negotiation

Requesting CRC Support:

Inquiries regarding the CRC Pool should be directed to somctucrcpool@uvahealth.org

Prior to beginning a work assignment, the assigned CRC(s) will need to complete all study-specific protocol training. Additionally, a study start-up meeting may be scheduled with the study team in order to ensure there is a clear understanding of expectations and scope of work.