CRSO study coordinators are available on a fee-for-service basis to assist investigators at all stages in the implementation and conduct of their clinical research studies. Study coordinators are available full- and part-time to support investigators with the following aspects of clinical research:
- Institutional Review Board submission process
- Preparation of regulatory documents
- Subject recruitment
- Informed consent process
- Subject registration for Children's Hospital systems
- Coordination of study activities
- Completion of case report forms
- Tracking and reporting of serious and non-serious adverse events
- Drug accountability
- Sample collection and processing
- Many other areas of study-related support.
Clinical Project Managers
The CRSO can provide clinical project managers (CPMs) to oversee and support clinical research studies being conducted at multiple institutions where Children's Hospital is either the sponsor of the study, the coordinating center, or the main trial site. CPMs provide leadership and are directly responsible for the implementation of study activities and site management for the multi-center clinical study protocol. They are responsible for providing supervision, training, support, and management for staff (direct and indirect), and ensuring compliance with study protocols and all Federal Drug Administration and National Institutes of Health regulatory policies.
Clinical Trial Monitors
The CRSO can provide clinical trial monitors to oversee the conduct of an Investigational New Drug or Investigational Device Exemption trial sponsored by a Children's Hospital investigator or for multi-site trials in which Children's Hospital is the coordinating center.
Clinical Research Associates
The CRSO offers Clinical Research Associates (CRAs) who monitor clinical trials to ensure protocol adherence, compliance with FDA regulations, study-specific operating procedures, ICH guidelines, and Good Clinical Practices (GCPs).
A CRA performs the following services:
- Conducts study site initiation and qualification visits
- Ensures subject eligibility and reviews the informed consent process and forms
- Serves as the primary resource for investigational sites and project team members
- Trains the site personnel regarding protocol requirements and adherence to GCPs and ICH guidelines
- Tracks and obtains outstanding regulatory documents from sites
- Ensures that regulatory files at the sites and study sponsor are current and in compliance with GCPs, including IRB approvals, informed consents, etc.
- Ensures adequate dissemination of information to relevant study personnel relating to adverse events (serious and non-serious) status and follow-up
- Provides clinical supplies, including case report forms and laboratory supplies, to study sites as requested