Support the Clinical Trial Manager with study start-up activities, to include preparing and/or reviewing study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines, study logs and forms Site Contracts and Budgets, Vendor Contracts and Budgets, etc.). Support the Clinical Trial Manager in formal risk assessment activities; review and corrective action plans across study, participates in the planning of quality assurance activities, internal and external audits/inspections, and coordinates communication of audit/inspection findings.