Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Job Summary

Are you ready to advance your career with an outstanding opportunity? As a Clinical Trial Coordinator at Thermo Fisher Scientific, you will play a vital role in our research efforts located in Argentina. This role is perfect for an ambitious individual eager to collaborate in a dynamic team that strives for outstanding execution and exceptional results.

Key Responsibilities

• According to the specific role, coordinates, oversees and completes functions on assigned trial(s) activities as detailed on the task matrix.
• Ensures allocated tasks are performed on time, within budget and to a high-quality standard.
• Proactively communicates any risks to project leads.
• Provides system support (i.e., Activate & eTMF) and ensures system databases are always current.
• Performs administrative tasks on assigned trials, including, but not limited to, timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members.
• Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
• Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
• Assists with study-specific translation materials and translation QC upon request.
• Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
• May support scheduling of client and/or internal meetings.
• May review and track of local regulatory documents.
• May provide system support (i.e., Activate & eTMF).
• May support the maintenance of study specific documentation and systems, including, but not limited to, study team lists, tracking of project specific training requirements, system access management and activity plans in appropriate system(s).
• Maintains vendor trackers.
• Supports start-up team in Regulatory submissions.
• Assists the project team with the preparation of regulatory compliance review packages.
• Provides support as needed to coordinate with internal departments, ensuring site start-tup activities within the site activation critical path are aligned.
• Works in collaboration with teammates to achieve targeted deadlines for assigned projects. Communicate with the team and appropriate clinical personnel regarding site issues and risks.

• Life science degree
• Proven experience in clinical trial coordination or a similar research role is preferred.
• Strong organizational skills with the ability to strictly manage multiple projects simultaneously.
• Outstanding communication skills to effectively collaborate with diverse teams.
• Ability to determine priorities and successfully implement project plans.
• Proficiency in English and Spanish, both written and verbal.

• Ability to work in a team or independently as required
• Good organizational skills and strong attention to detail, with shown ability to handle multiple tasks efficiently and effectively
• Shown 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
• Self-motivated, positive attitude and good social skills
• Effective oral and written communication skills
• Good social skills
• Essential judgment and decision-making skills
• Capable of accurately following project work instructions
• Independent thinker
• Ability to lead risk and perform risk escalation appropriately