Clinical Trial Coordinator

🔥 6 minutes ago

🇲🇽 Mexico – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

✨ Clinical Trial Coordinator

👻 Ghost score 10%

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Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

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 through scheduled department, internal, country, and investigator file reviews • Provide administrative support for site activation and help develop site activation critical paths • 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 • Document findings in appropriate systems and proactively communicate project risks • Provide support for Activate and eTMF systems and maintain current databases • Process and review eTMF documents, distribute mailings and communications, and provide reports to internal teams • Analyze and reconcile study metrics and findings reports • Coordinate Investigator Site File and Pharmacy binder materials and non-clinical study supplies • Support study-specific translation materials and translation quality control • Support client/internal meeting scheduling and local regulatory document tracking • Support RBM activities and study-specific documentation, training tracking, system access, and activity plans • Transmit documents to clients and centralized IRB/IEC • Maintain vendor trackers and support regulatory submissions • Work with sites to obtain site-selection documents and support regulatory compliance review packages • Coordinate with internal departments to align site start-up activities with the activation critical path • Complete Site Interest Plans in CTMS and collect associated investigator/site personnel documents when applicable • Document site communications, follow-ups, and survey responses in real time • Review survey data for logical, complete, and relevant responses • Collaborate with teammates and clinical personnel to meet project deadlines and address site issues and risks • Maintain site contact and follow-up plans and escalate non-compliance concerns • Act as a local expert on site capacity and experience, recommend additional sites, and support 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 • Use local knowledge to identify and develop new sites

🎯 Requirements

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification • Previous experience providing the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year) • Bachelor's degree preferred • Ability to work in a team or independently as required • Good organizational skills and strong attention to detail; ability to handle multiple tasks efficiently and effectively • Ability to analyze project-specific data/systems for accuracy and efficiency • Strong customer focus • Flexibility to reprioritize workload according to 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 • Proficiency in MS Office (Word, Excel, and PowerPoint) and ability to learn clinical trial database systems • Ability to complete the organization's clinical training program • Effective oral and written communication, interpersonal, judgment, decision-making, negotiation, risk-management, and work-instruction-following skills • High self-motivation and positive attitude • Occasional travel and drives to site locations may be required

🏖️ Benefits

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

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