Senior Clinical Research Associate at Rakuten Medical Inc. - US

United States

Company Profile Rakuten Medical, Inc. is a global biotechnology company developing precision, cell-targeting investigational therapies on its Alluminox™ technology platform, which utilizes antibodies conjugated with payloads that are specifically activated at the tumor site. Our first clinical product received marketing approval in Japan from the Ministry of Health, Labour and Welfare for ASP-1929 PIT to treat unresectable locally advanced or recurrent head and neck cancer - and is also in Phase III pivotal clinical testing globally to treat terminal cancer patients. This is a first-in-class product with unique pharmacological activity and with the potential to have a broad impact in cancer. Rakuten Medical is committed to its mission to conquer cancer and aims to realize a society where cancer patients can lead fulfilling lives. Headquartered in the United States, Rakuten Medical has 5 locations in 5 countries: the United States, Japan, Taiwan, Switzerland and India. For more information, visit www.rakuten-med.com. Position Summary 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. The ideal candidate will have experience in clinical trial operation (including site monitoring, CRO/Vendor management) with previous experience with oncology (head and neck cancer preferred), combination drug-device studies preferred. The candidate will have strong working knowledge of drug development process, GCP, ICH guidelines and FDA regulations. Key Duties and Responsibilities Site Monitoring and Compliance Management 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. Trial Master File (TMF) and Documentation Management 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. Study Materials and Training Support 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. Site Contracts and Vendor Support 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. Compliance with Regulatory and SOP Requirements Ensure all responsibilities are carried out in compliance with company regulations, safety policies, and standard operating procedures (SOPs). Clinical Trial Operational Oversight Project Lifecycle Management: Manage all operational aspects of clinical trials, from Study Start-up through Database Lock. Compliance and Quality: 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. Vendor and Stakeholder Management Vendor Management and Oversight: Responsible for the overall management and oversight of all study-related vendors, including Contract Research Organizations (CROs) and Contract Labs. Contracting, Procurement, and Finance: Review and provide input on vendor contracts and Statements of Work (SOWs). Assist with invoice reconciliation and financial tracking, as needed. Communication and Issue Resolution: Serve as the primary point of contact for key vendors and stakeholders. Responsible for managing and coordinating parties to effectively facilitate issue resolution. Clinical Compliance and Quality Control Investigational Product (IP) Management: Manage the Investigational Product (IP). Deviation Review: Review protocol deviations and data listings as needed to ensure sponsor oversight. SOPs and Processes: Assist in the development of internal SOPs and processes to ensure ongoing compliance and inspection readiness. Site engagement: build and maintain strong rapport and trust with investigators and other stakeholders Perform activities to ensure investigators and stakeholders 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. Desired Education, Skills and Experience Education & Experience Bachelor’s degree or equivalent in the life sciences or related field Minimum 3 years related industry experience with large company or 5 years with smaller company Previous experience with oncology (ideally head and neck cancer) and/or combination drug-device studies is preferred Communication & Interpersonal Skills Strong organizational and project management skills, including ability to multitask and organize/track information Positive, service-minded, and professional in all interactions Proactive recognition of issues as they arise with resolution and/or appropriate escalation to management as warranted Excellent interpersonal, written, and verbal communication skills Self-motivated and able to work independently with minimal supervision. Detail-oriented Able to collaborate and deliver results in a fast-paced environment. Strong computer skills and high level of proficiency with Microsoft Office (e.g. Word, Excel, PowerPoint, MS Project or other timeline management tool, Outlook) and Adobe Acrobat programs Other Ability and willingness to travel at times up to 60% nationally and internationally, depending on trial activities We are proud to offer a competitive compensation plan with an excellent benefits package including flexible time off, stock options, 401k, medical, dental, vision plans and more for full time employees. We recommend anyone coming onsite to be vaccinated for COVID-19. Rakuten Medical Inc. is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to building a team that represents a variety of backgrounds, perspectives and skills.