Clinical Trial Operations Specialist

2 semanas atrás

São Paulo, São Paulo, Brasil Thermo Fisher Scientific Tempo inteiro
Job Summary

We are seeking a highly organized and detail-oriented Clinical Trial Coordinator to provide administrative and technical support to our Project Team. The successful candidate will be responsible for ensuring audit readiness by reviewing files according to our SOP and department guidance document. Additionally, they will provide administrative support for site activation activities and aid in the development of the critical path for site activation within assigned projects.

Key Responsibilities
  • Support audit readiness by reviewing files according to our SOP and department guidance document
  • Provide administrative support for site activation activities
  • Aid in the development of the critical path for site activation within assigned projects
  • Represent CRG personnel and provide local input into the site tiering process
  • Act as a buddy during onboarding phase and provide training to new staff as needed
Requirements
  • High/Secondary school diploma or equivalent and relevant formal academic/vocational qualification
  • Bachelor's degree preferred
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year)
  • Ability to work in a team or independently as required
  • Good organizational skills and strong attention to detail
  • Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
  • Strong customer focus and flexibility to reprioritize workload to meet changing project timelines
  • Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout
  • Good English language and grammar skills and proficient local language skills as needed
  • Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems
  • Ability to successfully complete the organization's clinical training program
  • Self-motivated, positive attitude and good interpersonal skills
  • Effective oral and written communication skills
  • Good interpersonal skills and essential judgment and decision-making skills
  • Capable of accurately following project work instructions
  • Good negotiation skills and independent thinker
  • Ability to manage risk and perform risk escalation appropriately

Why Thermo Fisher Scientific?

We are a leading provider of scientific instrumentation and software, and we are committed to helping our customers advance their research and improve human health. Our team is passionate about delivering high-quality products and services, and we are looking for talented individuals who share our values and are committed to excellence.

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