Clinical Trial Coordinator

🔥 1 minute ago

🇲🇽 Mexico – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

✨ Clinical Trial Coordinator

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Provide administrative and technical support to the Project Team • Support audit readiness by ensuring files are reviewed according to organizational SOPs and department guidance • Provide administrative support for site activation activities and aid development of the site activation critical path • Develop and review site lists for feasibility activities and contribute local input to site tiering • Coordinate, oversee, and complete assigned trial activities according to the task matrix • Perform department, internal, country, and investigator file reviews and document findings • Ensure allocated tasks are completed on time, within budget, and to a high-quality standard; communicate risks to project leads • Provide system support for Activate and eTMF and maintain current system databases • Process documents to the Client eTMF, perform eTMF reviews, distribute communications, and provide documents and reports to internal team members • Analyze and reconcile study metrics and findings reports; assist with resolving site documentation findings • Coordinate, compile, and distribute Investigator Site File and Pharmacy binder materials and non-clinical study supplies • Support study-specific translation materials and translation quality control • Maintain knowledge of SOPs, client directives, and applicable regulatory guidelines • Support client/internal meeting scheduling, local regulatory document tracking, RBM activities, study documentation, training requirements, system access, and project activity plans • Transmit documents to the client and centralized IRB/IEC • Maintain vendor trackers • Support regulatory submissions and site selection document collection • Prepare regulatory compliance review packages • Coordinate with internal departments to align site start-up activities with the site activation critical path • Complete Site Interest Plans in CTMS and collect associated investigator and site personnel documents • Document communications, follow-ups, and survey responses in real time; review survey data for completeness and logical consistency • Collaborate with teammates and clinical personnel regarding site issues, risks, deadlines, and follow-up plans • Act as a local expert on site capacity and experience; recommend additional sites and perform local site tiering • Liaise with Global Investigator Services to resolve investigator queries and maintain account/contact information • Contribute to global strategic feasibility processes and best practices • Train new personnel in processes and systems • Utilize local knowledge to identify and develop new sites • Conduct on-site feasibility visits where applicable in Asia Pacific

🎯 Requirements

• Bachelor's degree • Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 0 to 1 year • An equivalency consisting of a combination of appropriate education, training and/or directly related experience may be considered sufficient • 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 • 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 • 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 • Good computer skills, proficiency in MS Office (Word, Excel, and PowerPoint), and ability to learn clinical trial database systems • Ability to successfully complete the organization's clinical training program • Effective oral and written communication skills • Essential judgment and decision-making skills • Ability to accurately follow project work instructions • Good negotiation skills • Ability to manage risk and perform risk escalation appropriately • Occasional driving to site locations and potential travel as required

🏖️ Benefits

• Fully remote work arrangement • Standard Monday–Friday work schedule

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