ProTrials Research Inc.

Clinical Operations

• Lead all clinical study operations, providing strategic/tactical planning, organization, and direction of study project(s) including but not limited to the oversight of clinical project timelines, reports, budgets, monitoring, site and vendor management, clinical supplies, and data collection
• Facilitate and foster positive, productive, and timely communication between sponsor, study team, and other functional groups
• Manage and motivate study team while serving as a mentor; mentorship may include identifying skills of the clinical team members and assisting with further professional development
• Provide proper financial oversight of study budget, including out of scope tracking, in conjunction with the Client Manager (CM) and ProTrials Finance Department
• Collaborate with senior management to provide study updates/progress, resourcing needs, sponsor issues, and health status at regularly scheduled intervals
• Drive the development, maintenance, and distribution of project plans based on project-specific requirements, throughout the life of the study (i.e., monitoring plan, communication plan, project management plan, eTMF plan, other plans as applicable)
• Manage studies in compliance with GCP, relevant SOPs, regulatory requirements, and project-specific plans
• Assess resourcing needs to ensure the study has the appropriate resources for the duration of the project
• Actively manage and track study risks (with team and sponsor input for potential obstacles that would delay the project’s progress while appropriately escalating issues
• Assess training needs of team members on the therapeutic area, protocol, special procedures/skills, and implement the appropriate training plans
• Delegate study team responsibilities and ensure that team members have the necessary tools and resources to effectively perform their role
• Monitor and manage the project’s progress and develop timelines with input from relevant stakeholders and sponsor approval; re-assess critical path for study progress and adjust timelines as needed
• Oversee activities and deliverables of outside vendors, as requested; ensure communication occurs between outside vendors, the team, and sponsor

Clinical Project Manager

Research Analyst

• Monitor clinical studies of investigational and approved products that have been determined to satisfy a medical need and/or offer a commercial benefit including qualification, initiation, interim, and close out site visits
• Manage and train site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion
• Manage, prepare, send, track, and return investigational supplies at individual sites
• Monitor and document investigational product dispensing, inventory, and reconciliation
• Monitor and document laboratory sample storage and shipment
• Monitor trial by reviewing and reporting on site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, and laboratory abnormalities
• Review source data and case report forms for accuracy, completeness, and integrity of the data, and identify and resolve ongoing data issues
• Review data queries and listings, and work with the study centers to resolve data discrepancies
• Review regulatory documentation for accuracy and completeness, and support study centers with regulatory issues
• Maintain complete and accurate study files and review files to ensure all appropriate documentation is present
• Maintain consistent and timely contact with the study centers, investigators, coordinators, client personnel, and other individuals involved in clinical trials
• Follow Good Documentation Practices, complete Visit Reports and site correspondence in accordance with SOPs

Clinical Research Associate

• Monitor clinical studies of investigational and approved products that have been determined to satisfy a medical need and/or offer a commercial benefit, including qualification, initiation, interim, and close-out site visits
• Manage and train site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion
• Manage and track the preparation and return of investigational supplies at individual sites
• Monitor and document investigational product dispensing, inventory, and reconciliation
• Monitor and document laboratory sample storage and shipment
• Monitor trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, and laboratory abnormalities
• Review source data and case report forms for accuracy, completeness, and integrity of the data, and identify and resolve ongoing data issues
• Review data queries and listings, and work with study centers to resolve data discrepancies
• Review regulatory documentation for accuracy and completeness, and support study centers with regulatory issues
• Maintain complete and accurate study files and review files to ensure all appropriate documentation is present
• Maintain consistent and timely contact with the study centers, investigators, coordinators, client personnel, and other individuals involved in clinical trials
• Serve as a resource for project team members including supporting CRA I and CRA II staff by providing solutions to resolve issues

Clinical Project Manager

Clinical Research Associate

Senior Clinical Research Associate