Clinical Trial Coordinator

🔥 55 minutes ago

🇧🇷 Brazil – 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 project teams • Support audit readiness through scheduled department, internal, country, investigator, and eTMF file reviews • Support site activation activities and critical-path development • Coordinate, oversee, and complete assigned trial activities according to task matrices • Perform file reviews and document findings in appropriate systems • Ensure assigned tasks are completed on time, within budget, and to quality standards • Maintain Activate, eTMF, CTMS, vendor trackers, study documentation, training records, system access, and activity plans • Process and transmit documents to client eTMF and centralized IRB/IEC • Analyze and reconcile study metrics and findings reports • Coordinate Investigator Site File and Pharmacy binder materials and non-clinical supplies • Support study-specific translation materials and translation quality control • Support client and internal meeting scheduling • Support regulatory document tracking and regulatory submissions • Obtain site-selection documents directly from sites • Assist with regulatory compliance review packages and site start-up coordination • Complete Site Interest Plans and collect associated investigator/site 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 manage site issues, risks, deadlines, and follow-up plans • Provide local expertise on site capacity, experience, tiering, and identification of new sites • Liaise with Global Investigator Services to resolve investigator queries and maintain account/contact information • Contribute to global feasibility processes and best practices • Train new personnel in processes and systems • Conduct on-site feasibility visits where applicable in Asia Pacific

🎯 Requirements

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification • Previous experience comparable to 0 to 1 year • Bachelor's degree preferred • Equivalency through a combination of appropriate education, training and/or directly related experience may be considered • Good English language and grammar skills and proficient local language skills as needed • Proficiency in MS Office (Word, Excel, and PowerPoint) • Ability to learn and master clinical trial database systems • Ability to successfully complete the organization's clinical training program • Knowledge of applicable country regulations, ICH Good Clinical Practices, and organization/client SOPs and WPDs • Ability to work independently or in a team • Strong organizational, analytical, communication, negotiation, judgment, decision-making, and risk-management skills • Ability to follow project work instructions accurately • Occasional driving to site locations and potential travel

🏖️ Benefits

• Fully remote work arrangement • Standard Monday–Friday work schedule • Potential occasional travel • Training and onboarding support • Opportunity to act as a buddy during onboarding and provide training to new staff

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