Clinical Operations Associate

hace 2 días

Xico, México Thermo Fisher Scientific A tiempo completo
{"title": "Clinical Operations Associate", "content": "Job Summary

We are seeking a highly organized and detail-oriented Clinical Operations Associate to join our team. As a Clinical Operations Associate, you will provide administrative and technical support to our project teams, ensuring the smooth execution of clinical trials.

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 appropriate systems.
  • Ensure allocated tasks are performed on time, within budget, and to a high-quality standard, proactively communicating any risks to project leads.
  • Support the maintenance of study-specific documentation and systems, including tracking project-specific training requirements and system access management.
  • Provide system support, including GoBalto and eTMF.
  • Support Risk-Based Monitoring (RBM) activities.
  • Perform administrative tasks, including timely processing of documents sent to clients, performing eTMF reviews, and providing documents and reports to internal team members.
  • Support scheduling of client and/or internal meetings.
  • Review and track local regulatory documents.
  • Transmit documents to clients and centralized IRB/IEC.
  • Analyze and reconcile study metrics and findings reports, assisting with clarification and resolution of findings related to site documentation.
  • Maintain vendor trackers.
  • 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.

Requirements

  • High/Secondary school diploma or equivalent and relevant formal academic/vocational qualification. Bachelor's degree preferred.
  • Previous experience providing 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.

Working Environment

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
Able to communicate, receive, and understand information and ideas with diverse groups of people.

"}

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