Rakuten Medical

Research Analyst

• The Senior CRA plays a critical role in supporting the clinical operations team throughout the conduct of clinical trials.
• This position primarily focuses on trial planning, site monitoring, data quality oversight, as well as study tracking and reporting.
• Conduct regular monitoring visits to ensure the trial is conducted in accordance with the protocol and that subject safety is maintained. Verify data accuracy through comprehensive Source Document Verification (SDV).
• Ensure investigational products, biological samples, and study supplies are handled according to applicable requirements, including receipt, storage, return, destruction, and accountability.
• Maintain the electronic and/or paper Trial Master File (TMF) to ensure proper documentation standards are met and tasks are performed independently.
• Assist in the creation, distribution, management, and archiving of essential clinical trial documents.
• Assist in the preparation and maintenance of study-related materials, including but not limited to site and CRA training materials, regulatory document templates, study binders, study plans, communication records, and presentation materials.
• Support training activities for clinical research teams and site staff.
• Assist in the execution and management of site-related contracts.
• Support the review of vendor and site contract terms and verify associated invoices for accuracy and compliance with budget.
• Ensure all responsibilities are carried out in compliance with company regulations, safety policies, and standard operating procedures (SOPs).
• Manage all operational aspects of clinical trials, from Study Start-up through Database Lock.
• Ensure all activities adhere to stated goals, timelines, budgets, and strictly comply with applicable regulatory requirements, ICH/GCP, and Standard Operating Procedure (SOP) standards.
• Provide sponsor oversight of the CRO activities for the Global Phase 3 trial.
• Responsible for the overall management and oversight of all study-related vendors, including Contract Research Organizations (CROs) and Contract Labs.
• Review and provide input on vendor contracts and Statements of Work (SOWs).
• Assist with invoice reconciliation and financial tracking, as needed.
• Serve as the primary point of contact for key vendors and stakeholders. Responsible for managing and coordinating parties to effectively facilitate issue resolution.
• Investigational Product (IP) Management: Manage the Investigational Product (IP).
• Review protocol deviations and data listings as needed to ensure sponsor oversight.
• Assist in the development of internal SOPs and processes to ensure ongoing compliance and inspection readiness.
• Build and maintain strong rapport and trust with investigators and other stakeholders.
• Perform activities to ensure investigators and stakeholders are equipped with relevant information/knowledge to perform the studies as requested by the company.
• Provide necessary on-site assistance and guidance to trial centers (sites) to support their execution of Photoimmunotherapy (PIT), assuming a role similar to that of a Field Clinical Technician (FCT), when required.
• Other duties as mutually agreed between the candidate and the company.

Senior Clinical Research Associate