ProTrials Research Inc.

Clinical Specialist

• Document study plans for distribution to the team, sponsor, and ProTrials management; review and update study plans throughout the project
• Develop and/or review study documents, including Protocol, Investigator Brochure, ICF, CRFs, Operations Manual, study aids, and site budget
• Oversee and support feasibility through collection and review of site capabilities information
• Manage, review, and approve essential study documents for site activation
• Lead study start-up and site close-out activities; organize and execute tasks and lead or mentor staff supporting activations and closures
• Participate in TMF QC activities and audits; supervise TMF activities and inspection readiness; oversee TMF quality control reviews and deliverable quality
• Schedule and attend team meetings; track progress, status, minutes, newsletters, communications, and action items
• Provide status reports to sponsors, teams, and ProTrials management; disseminate documents and information to study sites
• Keep project leadership and CRA/CTA teams informed of site and study status
• Participate in selection and management of outside vendors and their deliverables
• Ensure compliance with local regulations, FDA/ICH, GCP guidelines, and company and sponsor SOPs
• Support investigator screening and selection
• Ensure CTA resource planning, study organization, deliverable and out-of-scope tracking, clinical supplies management, and data collection meet project requirements
• Mentor CTA team members and provide feedback and development support
• Update the PM on project progress, resource needs, sponsor issues, and team member performance
• Communicate sponsor requirements, instructions, and changes to the team
• Run and review time-code billing and provide feedback on trends and outliers
• Review and track site invoices and payments
• Contribute to regulatory authority inspection activities, mock inspections, and audits

Clinical Project Specialist