TRIO’s Clinical Research Associates (CRAs) have strong scientific backgrounds and extensive experience in clinical trials methodology and oncology. The excellence of their work demonstrates their commitment to professionalism and innovative problem solving. They ensure International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) compliance and data integrity at each site visit with consistent review of high-quality, on-time data. Many of TRIO’s CRAs are regionally-based in approximately 40 countries, which helps to maximize their time spent on site, reduce costs and improve the quality of life for our valued employees. As a result of this, we have extremely low staff turnover rates. Global systems, processes and tools provide the necessary support to create and maintain efficiency in the field.
The TRIO Monitoring Resources team is composed of:
- TRIO CRAs, home-based in North America and Europe
- Non-TRIO CRAs from Local Preferred Vendors and Partnering Local National Cooperative Groups coordinated by TRIO
- The Director
- The Associate Director
- CRA Managers
- CRA Trainers
- Executive Assistants
The goals of the Monitoring Resources Management team are to:
- Select experienced and educated CRAs
- Coordinate CRA initial study training and maintain qualified CRAs
- Ensure that all studies monitored comply with ICH/GCP,TRIO Standard Operating Procedures (SOPs), sponsor SOPs (when applicable) and local or national regulatory requirements
- Manage study progress through regular follow-up of each CRA’s activities with respect to study deadlines
- Develop study-specific documents such as the study-specific monitoring manual for CRAs
- Develop, implement and improve monitoring resources management tools according to sponsor needs
- Select Monitoring Preferred Partners
TRIO’s monitoring resources are dynamic and flexible. Our permanent CRAs are trained specifically for each respective study.
When working with preferred partners, TRIO also trains and manages CRAs who are employed by the partner itself. TRIO contracts monitoring services from Preferred Partners in countries where TRIO resources or infrastructure are unavailable.
Our highly experienced local CRAs are the primary point of contact for the study sites. They are responsible for monitoring and managing site activities throughout the clinical study. This includes performing site qualification, initiation, interim and closeout visits. All monitors are managed and trained globally by the TRIO Project Management team for a specific study, and by the TRIO Monitoring Resources Management team for monitoring aspects. When they join a study, each CRA participates in a rigorous, comprehensive and extensive training program in order to ensure consistency in site monitoring. TRIO provides CRAs with additional training through an ongoing medical educational course on cancer and its treatment (standard and investigational) and other educational material from major international cancer symposiums.
To ensure the best work possible, each CRA is supervised by a TRIO Monitoring Resources Coordinator located in the same region.