Clinical Site Management Contractor

SFRI is seeking a Clinical Site Management Contractor with mid-senior level experience in managing global and local clinical trials. This role requires strong project management capabilities, expert knowledge of CRIO setup and use, and the ability to oversee all aspects of site operations to ensure regulatory compliance, quality, and trial success.

Key Responsibilities

• Serve as the primary liaison for assigned clinical trial sites, managing communications and issue resolution
• Oversee daily site operations across multiple trials, both domestic and international
• Ensure compliance with ICH-GCP, FDA, and local regulatory requirements
• Lead site feasibility, site selection, site qualification, and activation processes
• Manage and track patient enrollment, visit completion, and retention metrics
• Monitor and report on site performance and adherence to study timelines
• Coordinate with internal and external stakeholders including sponsors, CROs, project managers, and investigators
• Train and support staff and site personnel in the use of CRIO (Clinical Research IO) system
• Lead the full setup and configuration of CRIO for each clinical study
• Manage and troubleshoot CRIO system issues as a superuser
• Maintain eSource documentation, eRegulatory files, scheduling, and logs within CRIO
• Review and maintain essential site regulatory documents including 1572s, CVs, ICFs, and IRB approvals
• Prepare and review monitoring visit reports, deviation logs, and site correspondence
• Support audit readiness and inspection preparedness activities at the site level
• Track study budgets, support finance teams with investigator payment documentation
• Identify site-level risks and propose mitigation strategies to project teams
• Generate weekly and monthly site status reports for sponsors and internal teams

Qualifications

• 5–8 years of experience in clinical site or project management for clinical trials
• Hands-on experience with CRIO setup, training, and use across multiple studies
• Strong knowledge of GCP, FDA, and international clinical trial regulations
• Demonstrated ability to manage both global and local trial site operations
• Excellent communication, time management, and organizational skills
• Comfortable working independently in a remote or hybrid setting

Preferred

• Experience with Phase I–III studies across multiple therapeutic areas specifically nutraceutical and supplement studies
• Experience with IRB communications and clinical trial budgeting

Location: San Francisco, CA (Hybrid Optional)

Contract Type: 3-6 months (with potential for extension)