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Rakuten Medical

Rakuten Medical, Inc. is a global biotechnology company in pursuit of conquering cancer.

Senior Clinical Research Associate

Research AnalystResearch AnalystFull TimeRemoteSeniorTeam 201-500Since 2010H1B No SponsorCompany SiteLinkedIn

Location

California

Posted

1 day ago

Salary

0

Seniority

Senior

Bachelor Degree3 yrs expEnglishGoogle Cloud Platform

Job Description

Senior Clinical Research Associate

Rakuten Medical

• 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.

Job Requirements

  • 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
  • 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
  • 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
  • Ability and willingness to travel at times up to 60% nationally and internationally, depending on trial activities.

Benefits

  • flexible time off
  • stock options
  • 401k
  • medical plans
  • dental plans
  • vision plans

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