Job Description. Creation and ownership of risk-based quality management and centralized monitoring processes, templates, and tools corporately and for applicable clinical trials. Review protocols to ensure the set-up, review, and reporting requirements for KRIs and QTLs can be met and are standardized. Provide input and lead the study risk assessment, and propose appropriate protocol-specific risk indicators for centralized monitoring. Support s...
Job Description. Collaborate with the Contracts department to set up new project codes in Costpoint. Ensure all project details (e.g., POP, funding amounts, and modifications) are accurately maintained in Costpoint. Monitor projects scheduled to end within the month and coordinate with the Contracts department as needed. Perform daily cash receipt entries, prepare reports and analyse, resolve processing issues, and coordinate with departments reg...
Job Description. Conducts clinical site audits (domestic and international) verifying regulatory compliance and protocol compliance. Verifies clinical compliance to applicable Standard Operating Procedures (SOPs) and regulations. Reviews clinical audit reports and provides guidance to auditors. Supports inspection readiness program. Serves as a subject matter expert for quality. Promotes quality by reviewing work instructions, providing training ...
Job Description. Ensures compliance with TRI Standard Operating Procedures, Food and Drug Administration and World Health Organization regulations and global regulations for the reporting of adverse events to regulatory agencies. Develops and ensures the uniform and timely processing of adverse event reports. Provides medical evaluation of adverse event reports. Performs various tasks in support of clinical research including the reporting, colle...
Job Description. Prepare, distribute, and track regulatory submissions including, drug and biologic Investigational New Drug Applications (INDs), Biologics License Application (BLAs), New Drug Application (NDAs), Investigational Device Exemption (IDEs), ensuring compliance in accordance with GCPs/ICH and all applicable FDA/other Regulatory Health Authority regulations. Prepare scientific and other regulatory documents for submission to the Food a...
Job Description. Supports the maintenance and upkeep of the Quality Management System. Maintains the Quality Assurance (QA) training program, document control, customer complaint program and CAPA program. Supports audits of clinical sites and vendors/suppliers. Supports internal audit program and performance metrics system for continual improvement. Manages the review cycle of QA controlled documents to assure practices reflect written procedures...
Job Description. Researches and identifies new opportunities and/or prospective clients in support of clinical research, communication, and IT services. Supports the preparation of proposals by coordinating cross-functional teams, conducting research, and liaising with vendors. Writes and copy-edits material such as proposal concepts, proposals, resumes, white papers, fact sheets, web content, press releases, and newsletter articles. Ensures logi...
