Assistant CRA - Site Support Solutions

Thermo Fisher Scientific

  • Nyanza, South Province Nairobi
  • Permanent
  • Full-time
  • 1 month ago
Job DescriptionJob DescriptionAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.Site Support Solutions:Lack of staffing availability at the site level is an area of tremendous need and is becoming a rate limiting factor to prevent some clinical research sites from accepting new studies and/or executing current studies. This unmet study support need may result in a negative impact on our clients and their ability to start new studies, rapidly enroll to existing studies, or keep up with data entry and other administrative burden. The Site Support Solutions team is designed to support our customers by providing a service solution for the tasks associated with the study conduct at the sites.Discover Impactful Work:The ACRA within Site Support Solutions will perform delegated activities at assigned investigator sites under the supervision of the Principal Investigator. Facilitates GCP, protocol adherence, patient safety, quality delivery, and customer satisfaction. Ensures compliance with PPD, sponsor, and site processes, as appropriate. Provides support with regards to site preparedness and logistics on assigned projects. Assists with site management tasks to ensure protocol, regulatory, and SOP compliance and to guarantee subject safety, data integrity, and site compliance. Travel to sites is required.A Day in the Life:The Assistant CRA may participate in tasks similar to the following, as delegated and supervised by the Principal Investigator:
  • Data entry
  • Essential document collection; regulatory and start-up activities
  • Query resolution
  • Chart abstraction
  • Revieing patient charts to support recruitment
  • Quality management and inspection readiness; identify and document protocol deviations
  • Tracking biopsies
  • Maintaining adequate study supplies inventory
  • Supporting development of materials and tools
  • Setting up electronic devices used in the study

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