Clinical Research Multisite Project Management
The Clinical Research Multisite Project Management Team provides services for multisite clinical trials where a UVA investigator is the overall lead PI or the primary PI at UVA. Our role is similar to that of a Contract Research Organization (CRO) that is responsible for the clinical and data coordination of clinical trials.
Clinical Research Multisite Project Management Services (may be contracted separately or comprehensively):
- Collaborate with PI and study team on Protocol, CRF development and IRB submissions.
- Assist in sub-contracting & budget development with non-UVA sites.
- Development of electronic case report forms in conjunction with Advarra EDC teams.
- Project management: study start-up (training of site staff, management of regulatory approvals or reliance agreements), interim-monitoring visits, regular data quality reviews, sponsor & FDA reporting, coordination of invoicing, study closeouts.
- Clinical Research Multisite Project Management support is charged at an hourly rate.
Inquiries regarding Clinical Research Multisite Project Management should be directed to somctumultisite@uvahealth.org