Operations

• Owns and executes site identification, feasibility, and selection strategy in partnership with Clinical Development and other stakeholders.
• Develops and maintains site feasibility tools (questionnaires, scoring, prioritization criteria) aligned with protocol needs.
• Leads feasibility outreach, evaluates investigator/site capabilities (patient access, competing trials, staffing, lab/diagnostic readiness), and recommends final site list.
• Oversee site management and continuously assess study performance, ensuring adherence to timelines and quality expectations.
• Lead Site Initiation Visits with strong, clear communication to set expectations and align site staff on study requirements.
• Accountable for site startup timelines and deliverables, including SIV readiness, regulatory collection, and activation decision-making.
• Tracks and unblocks CTA/budget execution, IRB/EC approvals, and essential document completeness.
• Ensures sites are trained on protocol, systems, and study workflows; confirms training completion and readiness for first subject first visit (FSFV).
• Oversees creation and execution of site activation plans with clear critical path, milestones, and risk mitigations.
• Establishes site performance expectations and KPIs (activation, enrollment, data quality, responsiveness, protocol adherence).
• Monitors performance dashboards and trends; leads remediation and escalation plans for underperforming or at-risk sites.
• Facilitates regular site touchpoints (e.g., monthly calls, recruitment reviews) to sustain momentum and troubleshoot barriers.
• Drives enrollment optimization strategies and supports sites with recruitment toolkit/materials as applicable.
• Conduct monitoring visits at assigned sites as needed to support quality, compliance, and enrollment goals.
• Lead and mentor the CRA team, hold regular meetings, and provide day to day guidance to drive efficiency, consistency, and high quality execution.
• Ensure all monitoring activities follow the Clinical Monitoring Plan, ICH GCP guidelines, and applicable local regulations.
• Review monitoring visit reports, data metrics, and protocol deviations to identify trends, risks, and opportunities for corrective or preventive action.
• Oversees management of protocol deviations, violations, and consent noncompliance; partners with QA/Medical as needed.
• Ensures inspection readiness at site and study levels; supports audits and inspections, including prep and follow-up actions.
• Contribute to the creation of training materials and train CRAs on study specific requirements, reinforcing compliance with all protocols and procedures.
• Address study specific questions, troubleshoot operational challenges, and manage escalations to resolution in a timely manner.
• Partner and support the Clinical Trial Manager (CTM) to provide operational expertise, status updates, and insight into study progress, risks, and obstacles.
• Ensure sites maintain complete and current Investigator Study Files and remain inspection ready at all times.

Senior Manager, Clinical Site Operations

Group Manager, Residential Installation Operations

Supervisor, Vegetation Management Operations – Central Valley / Central Coast

Operations Coordinator

Supervisor, Vegetation Management Operations – Central Valley, Central Coast