Clinical Operations Coordinator

4 semanas atrás

São Paulo, São Paulo, Brasil Thermo Fisher Scientific Tempo inteiro
About the Role

We are seeking a highly organized and detail-oriented Clinical Operations Coordinator to join our team at Thermo Fisher Scientific. In this role, you will provide administrative and technical support to our project teams, ensuring the smooth execution of clinical trials from start to finish.

Key Responsibilities
  • Coordinate and oversee trial activities, ensuring timely completion and high-quality standards.
  • Perform department, internal, country, and investigator file reviews, documenting findings in relevant systems.
  • Ensure allocated tasks are completed on time, within budget, and to a high standard, proactively communicating any risks to project leads.
  • Provide system support and ensure system databases are always current.
  • Perform administrative tasks, including processing documents, performing eTMF reviews, and distributing communications as needed.
  • Assist with coordination, compilation, and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
  • Assist with study-specific translation materials and translation QC upon request.
  • Maintain knowledge of and understand SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
  • Conduct on-site feasibility visits (APAC only) and support scheduling of client and/or internal meetings.
  • Review and track local regulatory documents and provide system support.
  • Support RBM activities and maintain study-specific documentation and systems.
  • Transmit documents to client and centralized IRB/IEC and maintain vendor trackers.
  • Support start-up team in Regulatory submissions and work directly with sites to obtain documents related to site selection.
  • Assist the project team with the preparation of regulatory compliance review packages and provide support as needed to coordinate with internal departments.
Requirements
  • High/Secondary school diploma or equivalent and relevant formal academic/vocational qualification. Bachelor's degree preferred.
  • Previous experience providing administrative and technical support to project teams, preferably in a clinical trial setting.
  • Ability to work in a team or independently as required, with good organizational skills and strong attention to detail.
  • Strong customer focus, flexibility to reprioritize workload to meet changing project timelines, and ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs.
  • Good English language and grammar skills and proficient local language skills as needed, with good computer skills and ability to obtain knowledge and master all clinical trial database systems.
  • Ability to successfully complete the organization's clinical training program, with self-motivated, positive attitude and good social skills.
About Us

Thermo Fisher Scientific is a global leader in the life sciences industry, committed to enabling our customers to make the world healthier, cleaner, and safer. We value the health and wellbeing of our employees and support individuals to create a healthy and balanced environment where they can thrive.

We are an equal opportunities employer and welcome applications from diverse candidates. If you are a motivated and detail-oriented individual with a passion for clinical trials, we encourage you to apply for this exciting opportunity to join our team at Thermo Fisher Scientific.

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