Clinical Trial Coordinator

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 a daring individual eager to collaborate in a dynamic team that strives for outstanding execution and exceptional results.

Key Responsibilities

• 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-up activities within the site activation critical path are aligned.
• Works in collaboration with teammates to achieve targeted deadlines for assigned projects.
• Connect with the team and appropriate clinical personnel regarding site issues and risks.

Requirements

• Life science degree
• Confirmed experience in clinical trial coordination or a similar research role is preferred.
• Strong organizational skills with the ability to closely handle multiple projects simultaneously.
• Outstanding communication skills to optimally collaborate with complementary teams.
• Ability to resolve priorities and efficiently implement project plans.
• Proficiency in English and Spanish, both written and verbal.

Knowledge, Skills, Abilities

• 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 solid understanding 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 digital literacy, 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 communication skills.
• Effective o