ProTrials Research Inc.

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 Research Associate

Senior Clinical Research Associate