Clinical Operations Associate I

hace 1 semana

Xico, México Thermo Fisher Scientific A tiempo completo
About the Role

We are seeking a highly organized and detail-oriented Clinical Operations Associate I to join our team at Thermo Fisher Scientific. As a Clinical Operations Associate I, you will play a critical role in supporting the delivery of clinical trials and ensuring the success of our projects.

Key Responsibilities
  • Provide administrative and technical support to project teams, including coordination of trial activities, file reviews, and documentation management.
  • Ensure audit readiness by reviewing files on schedule and documenting findings in accordance with organizational and departmental guidelines.
  • Coordinate and complete functions on assigned trials, including department, internal, country, and investigator file reviews.
  • Support the maintenance of study-specific documentation and systems, including tracking of project-specific training requirements and system access management.
  • Provide system support, including GoBalto and eTMF, and assist with RBM activities.
  • Perform administrative tasks, including timely processing of documents, performing eTMF reviews, and providing documents and reports to internal team members.
  • Support scheduling of client and internal meetings, review and track local regulatory documents, and transmit documents to clients and centralized IRB/IEC.
  • Analyze and reconcile study metrics and findings reports, and assist with clarification and resolution of findings related to site documentation.
  • Maintain vendor trackers and assist with coordination, compilation, and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
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, with proven ability to handle multiple tasks efficiently and effectively.
  • Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency.
  • Strong customer focus.
  • 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 PPD clinical training program.
  • Self-motivated, positive attitude, and good interpersonal skills.

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