Clinical Trials Research Services
The division offers the following services:
- Pairing Sponsors and Contract Research Organizations with qualified clinician investigators.
- Reviewing studies for scientific validity, institutional risk and adequate resources.
- Coordinating safety assessment of studies involving biohazardous agents for compliance with regulations and policies.
- Providing orientation and training for clinician investigators and site staff.
- Assisting with site feasibility assessment for potential studies.
- Collaborating with the Research Central Business Office for budget review of resources
Site management support
- Hiring and managing study site staff to support studies.
- Developing workflow processes for successful participant recruitment, and study implementation and management.
- Assisting with sponsor communication and monitoring.
- Conducting and coordinating study protocol assessments, specimen processing, and data collection.
- Guiding clinician investigators and staff to ensure compliance with applicable regulations, policies, and procedures including the protection of the safety, rights, and welfare of research participants.
Regulatory support and consultation
- Assisting with Kaiser Permanente Southern California Institutional Review Board submissions using the integrated Research Information Systems.
- Supporting and managing expanded access (compassionate use) studies and U.S. Food and Drug Administration submissions.
- Providing consultation on applicable federal and state regulations, and institutional policies and procedures.
- Assisting with quality improvement initiatives through standard operating procedure review and development.
- Reviewing for quality assurance and compliance to address and prevent noncompliance.
- Facilitating proper retention of study records.