BCIRG
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Monitoring Resources
CIRG Clinical Research Associates (CRAs), with their strong scientific background and exhaustive experience in clinical trials methodology and oncology, display professionalism and innovative problem solving. They ensure ICH/GCP compliance and data integrity at each site visit with consistent review of high-quality, on-time data. Many of the CIRG CRAs are regionally-based which maximizes the time spent on site, reduces costs, and improves the quality of life of our valued employees. CIRG thus boasts of low staff attrition rates. CIRG has monitoring services available in 45 countries. Global systems, tools and processes provide the support necessary to create efficiency in the field.
The team is composed of:
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The Director
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A Worldwide Senior Manager
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CIRG Clinical Research Associates (CRAs) - home-based in North America & Europe
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Non-CIRG CRAs - from sponsors, cooperative groups, local CROs managed and coordinated by CIRG
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CRA Managers for North America operations (based in Edmonton office) and for non North American operations (based in the Paris office)
- Executive Assistants
The Goals of the Central Monitoring Resources team are:
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To ensure that all studies implemented and conducted by CIRG are in accordance with the ICH/GCP guidelines, CIRG SOPs, sponsor SOPs when applicable, and local or national regulatory requirements.
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To maintain qualified CRAs through study-specific trainings, data validation procedural training.
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To manage study progress with respect to study & project deadlines through regular follow-up of each respective CRA's activities.
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To develop, implement and improve monitoring resources management tools according to sponsor needs.
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To hire experienced and educated CRAs.
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To negotiate and consolidate project budgets with all involved partners.
The monitoring resources used by CIRG are dynamic and flexible. CIRG has permanent CRAs who are trained for each respective study.
When working with Cooperative Groups, CIRG will also train and manage CRAs that are employed by the Cooperative Group itself. CIRG contracts monitoring services from Clinical Research Organizations or from the Sponsor's Affiliates in those countries where their own resources or infrastructure are not available.
THE CRAs ACTIVITIES ARE:
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Study site qualification,
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Study initiation visits,
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Study site monitoring and close-out visits,
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Source data verification,
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Problem resolution,
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Drug accountability reconciliation,
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Regulatory document maintenance,
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Site management activity to ensure successful study progress, includes:
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Visit correspondence and report,
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Telephone contacts,
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Maintenance of study tracking logs,
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Review of study materials,
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Assistance with patient recruitment.
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Data validation, and
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Query resolution.
TRAINING
All monitors are managed and trained globally by the Project Management team for a specific study, and by the CRA Management team for monitoring-specific issues. Upon hiring, each CRA participates in a rigorous, comprehensive and extensive training program in order to ensure consistency in site monitoring. In addition, CIRG offers an ongoing medical educational course on breast cancer and its treatment, both standard and investigational. Updates from major international cancer symposiums are presented and discussed.
CRAs do not perform alone until he/she has accompanied and trained with an experienced CRA in all types of monitoring visits. The CRA managers are seasoned monitors and have on average 3 to 5 years of experience.
Each new CRA is supervised by the CRA manager located in the same region. The supervisor guides new CRAs through training and development. The CRA Managers assess monitoring skills of the new CRA and bring them up to speed in the study/site setting.
