Clinical Trial Coordinator

🔥 9 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

• 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 project risks proactively to project leads • Provide support for Activate, eTMF and other clinical trial systems and keep databases current • Process documents for the Client eTMF, perform eTMF reviews, distribute mailings and communications, and provide reports • Analyze and reconcile study metrics and findings reports • Assist with resolving site documentation findings • Coordinate and distribute Investigator Site File and Pharmacy binder materials and non-clinical study supplies • Support translation materials and translation quality control • Maintain knowledge of SOPs, client directives and regulatory guidelines • Conduct on-site feasibility visits where applicable for Asia Pacific roles • Support client and internal meeting scheduling • Review and track local regulatory documents • Support RBM activities and study-specific documentation and systems • Transmit documents to the client and centralized IRB/IEC • Maintain vendor trackers • Support regulatory submissions • Obtain site-selection documents directly from sites • Prepare 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 and site personnel documents when applicable • Document communications, follow-ups and survey responses in real time • Review survey data for logical, complete and relevant responses • Collaborate with teammates and clinical personnel regarding site issues and risks • Maintain an efficient site-contact and follow-up plan and escalate non-compliance • Provide local expertise on site capacity and experience and recommend additional sites • Liaise with Global Investigator Services to resolve investigator queries and maintain account and contact information • Contribute to global 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 • Bachelor's degree preferred • Previous experience comparable to 0 to 1 year • Equivalent combination of appropriate education, training and/or directly related experience may be considered • Ability to work independently or in a team • Strong organizational skills and attention to detail • Ability to manage multiple tasks efficiently and effectively • Ability to analyze project-specific data and systems • Strong customer focus • Flexibility to reprioritize workload • Working knowledge of applicable country regulations, ICH Good Clinical Practices, 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) • Ability to learn and master clinical trial database systems • Ability to complete the organization's clinical training program • Effective oral and written communication skills • Judgment and decision-making skills • Ability to accurately follow project work instructions • Negotiation skills • Ability to manage risk and perform risk escalation appropriately • Occasional travel may be required • Occasional drives to site locations

🏖️ Benefits

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

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