Vanguard Clinical, Inc.

Clinical Operations

• The Clinical Operations Specialist (COS) is an experienced, cross-functional clinical research professional responsible for supporting and driving key operational activities across Clinical Operations, Study Start-Up (SSU), Trial Master File (TMF) Management, Data Management, Vendor Oversight, Site Support, and broader study execution.
• Lead administrative and operational coordination across the clinical trial lifecycle.
• Independently manage study trackers, site updates, enrollment metrics, and operational reporting.
• Prepare agendas, lead or co-lead portions of meetings, and finalize high-quality minutes and action items.
• Coordinate cross-functional workflows with CRAs, PMs, Data Management, SSU, Safety, and TMF teams.
• Provide proactive solutions and anticipatory support to internal teams and Sponsor clients.
• Independently manage essential document collection, QC, and readiness for site activation.
• Conduct feasibility outreach, site qualification support, and site-level intelligence collection.
• Lead start-up timeline tracking and drive accountability with sites and vendors.
• Perform advanced QC review for TMF documents and root-cause identification for recurring issues.
• Independently manage TMF filing, metadata application, and cross-checking for document dependencies.
• Support audit/inspection readiness, including TMF remediation, reporting, and corrective action follow-up.
• Perform high-level clinical data review in EDC systems; generate and track complex queries.

Clinical Operations Specialist – Pool

• Provide administrative and operational support across the clinical trial lifecycle.
• Track study metrics (enrollment, screening, recruitment, site updates).
• Assist in preparing and documenting meeting materials.
• Schedule and coordinate meetings.
• Prepare, ship, and track investigational products and study supplies.
• Support collection, tracking, and review of essential documents.
• Assist with feasibility, qualification, and regulatory document management.
• Support IRB/EC submissions and ICF preparation.
• Track study start-up timelines and follow up with sites and vendors.
• Perform QC review of TMF documents.
• File documents per TMF Reference Model.
• Identify gaps, inconsistencies, and missing documentation.
• Support audit and inspection readiness.
• Review and enter clinical data into EDC systems.
• Manage data queries, reconciliation, and quality control checks.
• Support documentation review and source verification activities.
• Provide customer service to clients, vendors, and sites.
• Draft or update trackers, presentations, and study reference materials.
• Support cross-functional initiatives and process improvements.
• Participate in study meetings and assist with follow-up actions.

Clinical Operations Specialist – Pool

Clinical Operations Associate